1 Clinical Problem Social Anxiety is described by .docx

1
Clinical Problem
Social Anxiety is described by The Diagnostic and Statistical
Manual of the American
Psychiatric Association (DSM-5) as a persistent fear of social
situations where the person is
exposed to people or to possible scrutiny by others and fears
that he/she will display
symptoms of anxiety or be perceived in a way that will be
embarrassing and humiliating
(American Psychiatric Association, 2013). This topic was
chosen as according to Kessler et
al. (2012) social anxiety is among the most common anxiety
disorder affecting 13% of
individuals at some stage in their lives. From experience, and
according to Krysta et al.
(2015) medication is the first line treatment for anxiety
disorders due to accessibility.
Unfortunately, for people experiencing social anxiety most
medications have adverse effects

such as increased agitation and sexual dysfunction (Rosen et al
1999) and some medication,
in particular benzodiazepines are highly addictive (Lader and
Kyriacou, 2016). Townend et
al. (2008) report that CBT remains the psychological therapy
with the widest and broadest
evidence base. Beck et al (1979) define Cognitive Behavioural
Therapy (CBT) as a concept
where an individual’s emotions and behaviours are based on the
way that they interpret the
world through their cognitions. NICE (2011) (cited in Clark,
2011) recommend psychological
therapies prior to medication for anxiety disorders however due
to a lack of therapists in
mental health services this is not the case in clinical practice
which led to the rationale for the
following research question.
2

Clinical question
Are psychological interventions more efficacious than
pharmacological interventions to help
reduce social anxiety disorder (SAD) symptoms in adults?
Bragge (2010) explains that answerable clinical research
questions have four essential
components known as PICO. This therapy type question was
developed using these
components (P) Population: adults that experience social
anxiety (I) Intervention:
Psychological interventions (C) Comparator: Pharmacological
Interventions (O) Outcome:
reduction of social anxiety symptoms.
Search Strategy and Outcome
A systematic literature search was carried out using electronic
databases which were
individually accessed via Queens Online, including MEDLINE,
Science Direct, PschINFO
and Cochrane (see Appendix 1). Roberts and Dicenso (1999)
suggest that questions in
relation to interventions and their effectiveness are best
answered by randomized control

trials or based on the hierarchy of evidence, systematic reviews.
BestBets.org was also
accessed for evidence based synopses.
The three papers the author deemed relevant to answer the
clinical question above are as
follows;
Clark et al. (2003)
Nordahl et al (2016)
Davidson et al. (2004)
3
These three studies were chosen as their methodological design
appeared to answer the
clinical question posed. They were critically appraised using the
Critical Appraisal Skills
Programme (CASP UK, 2017) relevant tool as a foundation.
Nadelson and Nadelson (2014)
teaches that the CASP tools effectively cover the areas needed
to critically appraise evidence.
Initially, presumptions were made that databases would be
inundated with literature on this

topic but it became apparent that limited appropriate journals
were available. On reflection,
individuals with social phobia find it difficult to engage for fear
of being negatively appraised
(Amir et al. 2009), and therefore would find it difficult to
engage with psychiatric services
and clinical trials.
Critical appraisal
The randomized placebo-controlled trial by Clark et al. (2003)
set out to compare cognitive
therapy with fluoxetine in generalized social phobia. Sixty
patients aged between 18 and 60
years of age with a diagnosis of generalized social phobia as per
the DSM-IV criteria were
randomly assigned to three arms; Cognitive therapy, Fluoxetine
+ self-exposure and placebo
+ self-exposure.
The study by Clark et al. (2003) addressed a clearly focused
issue as the population studied,
the intervention given and the comparator are all presented in
the main body of the article
however, the outcomes are not clearly specified. Stanley (2007)
highlights that a primary

outcome will decide on the overall result of the study, adding
that an RCT must have only
one primary outcome and should be clearly defined. Stratified
randomisation was carried out
including two variables; gender and avoidant personality
disorder and allocation concealment
followed which both decrease bias and increase validity.
Stratified randomization, uses
random selection within each strata in an attempt to ensure that
no bias, deliberate or
4
accidental, interferes with the representative nature of the
patient sample (Altman & Bland
1999). Allocation to fluoxetine or placebo were double blinded,
this is important as blinding
seeks to reduce performance and ascertainment bias after
randomization (Altman & Schulz
2001). The groups appear to have been treated equally as
assessments were carried out by an
independent assessor which reduces bias and therefore increases
validity.

The study provides a paragraph of the patient’s characteristics
and emphasises that there were
no significant differences between the arms. A table of patient
characteristics and distribution
to arms would have made this clearer and limit any doubt of
bias. An explanation for the
patients that dropped out was also provided, however, a
CONSORT flow chart which would
show the flow of participants through each stage of the study
would have made it clearer.
An intention to treat (ITT) analysis was utilised and dropouts
were accounted for. ITT is a
strategy for the analysis of RCT’s that compares patients in the
original groups to which they
were randomly assigned (Hollis & Campbell 1999). ITT
analysis ensures true effects of a
study by accepting that noncompliance and protocol deviations
are likely to occur in actual
clinical practice (Gupta, 2011). ITT analysis therefore avoids
bias, as without it researchers
could selectively exclude participants from the groups they
were randomized to. Clark et al.
(2003) reported that they employed a self-report measure
developed by themselves which

could introduce bias and would make it difficult for other
researchers to replicate this study.
Overall, the researchers of this study appear to have covered
sufficient aspects to ensure
internal validity.
The randomised clinical trial by Nordahl et al. (2016) aims to
evaluate whether Paroxetine
(SSRI) is more effective than Cognitive therapy and whether a
combination of the treatments
is more effective than the single interventions in the treatment
of Social Anxiety Disorder
5
(SAD) with and without avoidant personality disorder (APD).
102 participants were
randomly allocated to four arms of the trial; Paroxetine, pill
placebo, Cognitive therapy (CT),
and a combination of Paroxetine and CT.
The study by Nordahl et al. (2016) clearly addressed a focused
issue as the population,
intervention, comparator and outcomes were clearly identified.
The rating scales ADIS-IV,

SCID-II, both the primary outcomes and the secondary
outcomes were rated and assessed by
independent evaluators increasing validity. However, it could be
suggested that these
independent assessors were blinded also as Karanicolas et al.
(2010) reports that bias can be
introduced both intentionally and unintentionally.
Similar to Clark et al. (2003) stratified randomization was
carried out to ensure equal
distribution of gender and Avoidant Personality Disorder (APD)
increasing validity.
According to Hidalgo et al. (2001) there is a higher incidence of
SAD in women with
Eikenaes (2015) adding that there is an uncertainty whether
APD and SAD are different
disorders, or are different degrees of severities of SAD. Triple
masking of the patient,
psychiatrist and principle investigator was carried out for the
arms receiving pills
(paroxetine/placebo), the goal of masking is to minimize
potential biases (Forder et al. 2005)
which therefore increases validity of the trial. The study also
informs us that 15% of the

patients were interviewed by telephone which could introduce
bias as not all the patients were
treated the same. As psychiatrists and therapists were all
experts in this study, allegiance bias
may have been introduced, allegiance bias in psychotherapy
outcome studies refers to the
results being distorted by the investigators’ theoretical or
treatment preferences (Wilson et al.
2011). Overall, the researchers appeared to cover sufficient
aspects for the reader to accept its
validity.
6
The randomized double blind placebo controlled trial by
Davidson et al. (2004) compared
fluoxetine (FLU), comprehensive cognitive behavioural group
therapy (CCBT) , placebo
(PBO) and the combinations of CCBT/FLU and CCBT/PBO to
treat generalized social
phobia over a 14 week period. 295 participants were randomized
evenly into the 5 arms,

primary outcomes were measured with the Brief Social Phobia
Scale and Clinical Global
Impressions scales and the secondary outcome was a videotaped
behavioural assessment
using the Subjective Units of Distress Scale (SUDS).
An evaluator independent from the team was blinded and
assessed both the primary outcomes
reducing bias and increasing validity. The study was carried out
at two academic outpatient
psychiatric centres in Durham and Pennsylvania covering large
populations.
Block randomization was carried out by a computer program
which reduces bias however the
researchers admit that this was not fully adhered to as they
‘balanced CCBT groups to
include at least 2 women and 2 men’ introducing selection bias
and decreasing the validity of
the study.
Compliance to medication was monitored by pill counts at each
visit and reviewing daily
medication logs. The validity of the study would have been
increased if blood tests had been
carried out by an independent laboratory to ensure compliance.
High degrees of non-

adherence in randomized controlled trials (RCTs) can lead to
failure to detect a true treatment
effect (Murali et al. 2017).
Primary outcomes measures were assessed by a blinded
independent evaluator increasing
validity. Blinding of data collectors and outcome adjudicators is
crucial to ensure unbiased
ascertainment of outcomes (Karanicolas et al. 2010) but the
blinding process was not
evaluated which leads to doubts whether blinding was
successful.
7
Internal validity is questioned in this trial as there are
possibilities for bias, furthermore the
duration of the trial lasted only 14 weeks, and therefore results
are to be viewed with caution.
Results:
In Clark et al. (2003) social phobia was measured on a social
phobia composite which was
based on seven individual social phobia measures. There was a

large effect size for Cognitive
therapy (CT) at posttreatment (1.31) and a small treatment
effect for Fluoxetine and self-
exposure (0.21) based on Cohen’s (1988) (cited in Clark et al.
2003) threefold classification
of effect size. Rice (2009) teaches that the larger the effect size,
the more powerful the
treatment intervention. Paired comparisons indicated that CT
was superior to fluoxetine +
Self exposure and Placebo + self-exposure on the social phobia
composite scale (group effect
9.5=p<.001.) and all seven individual measures at
posttreatment. Surprisingly, there was no
statistical significance between Fluoxetine+ Self-exposure
(effect size 0.92) and the control
Placebo+ self-exposure (effect size 0.56), post treatment.
In Nordahl’s et al. (2016) study, the primary outcome was
measured by the level of
symptoms on the Fear of Negative Evaluation questionnaire
(FNE). There were three
secondary outcome measures; Liebowitz Social Anxiety Scale
(LSAS), the Beck Anxiety
Inventory (BAI) and the Inventory of Interpersonal Problems
(IIP). This study resulted that

the combination group (Paroxetine and CT) were equal to the
Paroxetine group, post
treatment (mean difference = -2.166, p=0.806) on the FNE. At
the 12 month follow up there
was no difference between CT and the combination group,
however both were more effective
than the placebo and Paroxetine arms. On the secondary
measure the LSAS the CT group
alone performed better than any of the other 3 arms at the 12
month follow up. Of great
significance were the recovery rates 68% of the CT group
compared to 45% of the
8
combination group, 23% in the paroxetine group and 4% in the
placebo arm. Effect sizes
were high suggesting both clinical and statistical significance.
Davidson et al. (2004) resulted in Fluoxetine alone producing a
p value of <.01 from 0-4
weeks. At the end of treatment (14 weeks) a statistical
significance was established in all
arms except the placebo group on the primary outcome Brief

Social Phobia Scale (BSPS) and
the secondary outcome Social Phobia and Anxiety Inventory
(SPAI) indicating a p value of
<.05 and a confidence interval of 95%. However on the Clinical
Global Impressions Scale
(CGI), the second primary outcome, Fluoxetine and the
combination of CCBT+FLU were
superior at the end of treatment (p=.01) but no statistical
difference for CCBT or CCBT/PBO.
Du Prel et al. (2009) explain that a Confidence Interval (CI)
predicts the precision of the
results. If the CI is wide, the estimate of true effect lacks
precision and therefore doubts the
treatment effect. If the confidence interval is narrow, precision
is high, and we can be more
confident in the results. There was no statistical difference
between combined therapies and
monotherapies.
Clinical Bottom line
Based on the evidence from the above three studies,
psychological therapy, in particular a
form of CBT, and pharmacological therapy, in particular, a
SSRI, are both effective at

reducing symptoms of SAD, however, Cognitive Therapy was
superior in the long term in
two out of three of the studies. Interestingly, there was no
evidence found that a combination
of both interventions were more effective than their
monotherapies on recovery rates.
9
Applicability to Practice
In order for a trial to be clinically useful the results must also
be relevant to a definable group
of people in a clinical setting, this is known as external
validity/applicability (Rothwell 2005).
It is not stated where Clark et al. (2003) trial was carried out,
Davidson et al. (2004) study
was based in North Carolina and Philadelphia and the RCT by
Nordahl et al. (2016) was
carried out in Norway. The aforementioned increases external
validity as results are
applicable to the various nationalities in the local population.

All three studies utilised the
DSM and the majority of the outcome measures are utilised in
current practice indicating that
the results can be applied to the local population.
Clark et al (2003) and Nordahl et al. (2014) both had small
sample sizes assessing
approximately 20 participants per treatment group at post
treatment assessments reducing
applicability, as Everitt and Wessely (2004) report that a large
sample size is more
representative of the population and minimises random error.
The inclusion and exclusion criteria are well defined for all
three studies, participants were
both male and female with a primary diagnosis of social anxiety
disorder with Clark et al.
(2004) and Nordahl et al. (2016) both including avoidant
personality disorder but excluding
depression. This could limit the generalisability of these results
as the majority of the patients
that come in contact with the mental health services in Ireland
present with comorbid
psychiatric problems such as depression. This is supported by
Magee et al. (1996) who report

that 81% of people that experience social anxiety disorder
reported experiencing another
disorder with Katzelnick et al. (2001) adding that up to 35% of
sufferers of SAD experience
major depression with SAD preceding depression up to 12
years.
10
Despite these results, the majority of patients in the local area
being treated for social anxiety
are receiving some form of anti-depressants as the waitlist for
CBT is 3 months or more with
Magee et al. (1996) adding that people with social anxiety do
not regard themselves as
suffering from an anxiety disorder, but shy, and do not seek
help until comorbid disorders
such as depression, affect them.
Implementation
Whilst researching for this critically appraised topic it became
apparent the lack of RCT’s
and therefore, systematic reviews, that compare psychological
and pharmacological

interventions for SAD. The Cochrane Journal club was
suggested by the hospital librarian,
this club is aimed at healthcare professionals and covers a
single review of special interest,
selected from the new and updated reviews published in the
Cochrane Library. Lawrie et al
(2003) also suggests that mental health professionals establish a
local evidence-based
psychiatry journal club (EBPJC) which would develop critical
appraisal techniques and
encourage the implementation of evidence based practice.
Grol and Grimshaw (2003) reported that one of the most
consistent findings in health services
research is the gap between evidence based practice (EBP) and
actual clinical care. Grol and
Wensing (2004) reports that studies in countries such as the
United States and the
Netherlands suggest that up to 40% of patients do not receive
care according to current
scientific evidence, while 20% or more of the care provided is
not needed or potentially
harmful to patients.
In a study carried out by Melnyk et al. (2012) on nurses in the

United States, the two most
frequently cited barriers to EBP, were a lack of time and a
workplace resistance, mostly from
11
management, to change. This study proposes that EBP mentors
work alongside clinicians to
facilitate learning these skills and implement them into practice
consistently. Facilitation is
considered necessary for enabling successful implementation
and is described by Rycroft-
Malone, (2004) as the process of supporting the implementation
of evidence into practice and
support to aid nurses alter their attitudes and ways of working.
Organizations need to consider resources required for EBP as a
lack of resources are
unfavorable to the success of implementation (Dogherty et al,
2013), financial, personnel,
equipment, support, access to evidence, and time are all forms
of resources. From experience
as a mental health nurse, lack of time to access library facilities
and lack of

motivation/support to implement new practice are the main
restraining factors for frontline
staff. Thompson et al. (2008) supports this by pointing out that
busyness, in the context of
research utilization, includes multiple dimensions such as
physical time, but perhaps more
importantly, mental time.
It is evident in practice that mental health nurses are not
familiar with CBT techniques or the
benefits despite many years of experience as mental health
nurses. Most educational
institutions in Ireland do not provide basic psychological
therapy training to mental health
students, however, there is an emphasis placed on
pharmacology. It is important that
organizations examine existing resources that could be utilized
to promote change, that is,
facilitate nurses to attend training days, encouragement of
research, time allocated for
research and encourage staff to return to education on a part
time basis by providing
incentives such as; funding, study days and instill hope of post
progression/promotion
following their studies.

Lewin’s (1951) (cited in Bowers 2011) proposed a three-step
process to change management
which offers a structured approach to understanding and
changing behaviour in the workplace.
http://onlinelibrary.wiley.com/doi/10.1111/wvn.12009/full#wvn
12009-bib-0023
http://journals.rcni.com.queens.ezp1.qub.ac.uk/doi/full/10.7748/
ns.30.1.38.e9296
12
It relates well to healthcare practice, as its three stages of
‘unfreezing’, ‘moving’ and
‘refreezing’ are similar to the healthcare processes of
‘planning’, ‘implementing’ and
‘evaluating’ care. This process is outlined with the clinical
bottom line of this critical
appraisal in mind and focusing on the psychological therapy,
CBT.
Unfreezing/Planning: Approaching management with the
findings of this appraisal that
psychological therapies are more beneficial than
pharmacological therapies and the most cost
effective therapy for health services (Mavranezouli 2015). A
proposal would be presented to

hold workshops to educate mental health colleagues on the
evidence based benefits of CBT
and the basic techniques of CBT. Gage (2013) emphasize that
support must be gained from
senior management who have an appropriate area of
responsibility, and who would benefit
from this service improvement idea and support the
implementation of the project.
Moving/Implementing: Nursing staff acquire basic CBT skills
and implement them into daily
practice. Gage (2013) reports that if staff are involved in change
from the early stages they
are more likely to feel more invested in assisting with the
delivery of the change plan, with
Hall and Hord (2011) adding staff are more likely to accept
change than if it is not imposed
on them ‘from above’.
Refreezing/ evaluation: Staff to monitor for a decrease in
symptoms of SAD. Parkes and
O’Dell (2015) report that if changes are implemented it is
imperative that these changes are
audited to ensure the continued provision of quality care.
If the above implementation plan was a success, Mental Health

Nurses could then practice
basic CBT techniques with patients while they await an
appointment from a qualified
therapist. As a result, patients would then know what to expect
from therapy, attend their
appointment and limit the chance of deterioration. In addition,
it may encourage nursing staff
to return to higher education to train as Cognitive Behavioural
Psychotherapists.
13
Appendix 1: Search Strategies
Search on Medline: After using additional keywords and filters
my search finally resulted in 1 text
being retrieved Clark et al (2003) and deemed as appropriate for
critical appraisal following the
reading of each abstract. Filters used were: full text, published
in peer review journals and that the
keywords would be in the title of the text.
SEARCH MEDLINE: Key Words and Boolean Operator HITS
S1 Social Phobia 3410

S2 Cognitive therapy 21864
S3 Fluoxetine 11846
S4 1 AND 2 AND 3 17
Search on PsycINFO: The key words used were CBT, anxiety
and depression. The Boolean operator
AND was used. Filters were: journals, full text and that the
keywords would be in the title of the text.
Following inspection of the abstracts one was chosen for critical
appraisal (Nordahl et al. 2016)
SEARCH PsycInfo
Key Words and Boolean Operator
HITS
S1 Social Anxiety Disorder 4078
S2 Cognitive therapy 6863
S3 Paroxetine 958
S4 1 AND 2 AND 3 2

14
Search on Science Direct: Filters were: journals, full text,
keywords would be in the title of the text
and year limit from 2014-2017 to locate the most recent
evidence. Following inspection of the
abstracts none was deemed appropriate for critical appraisal
SEARCH ScienceDirect
HITS
S2 AND psychological and Pharmacological
Interventions
331
Search on Cochrane: Following inspection of the abstracts one
was chosen for critical appraisal
(Davidson et al. 2004).
SEARCH Cochrane

HITS
S2 AND Fluoxetine 33
15
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Psychology of the American
Psychological Association, 18(2), 119–125.
A Randomized Trial to Promote Physical Activity Among
Breast
Cancer Patients
Bernardine M. Pinto
The Miriam Hospital, Providence, Rhode Island, and W. Alpert
Medical School of Brown University
George D. Papandonatos
Brown University

Michael G. Goldstein
VHA National Center for Health Promotion and Disease
Prevention, Durham, North Carolina
Objective: Physical activity (PA) has been shown to provide
health benefits for breast cancer patients. The
effects of augmenting oncology health care provider (HCP)
advice for PA with 3 months of telephone
counseling versus contact control were evaluated in a
randomized trial. Methods: After receiving brief HCP
advice to become physically active, 192 women (age in years:
M � 60.0, SD � 9.9) who had completed
treatment for Stage 0-IV breast cancer were randomized to
telephone counseling to support PA (n � 106) or
contact control (n � 86). Their PA, motivational readiness,
fatigue, and physical functioning were assessed
at baseline (before receiving HCP advice), 3, 6, and 12 months.
Results: Telephone counseling produced
significant effects on the primary outcome of moderate-intensity
PA of about 30 min/week at both 3 months
(95% CI � 0.44, 57.32) and 6 months (95% CI � 3.06, 61.26).
Intervention participants were also more than
twice as likely as control participants to report improvements in
achieving PA guidelines of at least 150
min/week at 3 (OR � 2.43, 95% CI � 1.18, 4.98) and 6 months
(OR � 2.11, 95% CI � 1.00 – 4.48).
Telephone counseling was significantly more effective than
contact control in increasing motivational
readiness for PA at all follow-ups (ORs � 3.93– 6.28, all ps
�.003). No between-groups differences were
found for fatigue, while differential improvements in physical
functioning did not remain significant past 3
months (p � .01). Conclusion: HCP advice plus telephone
counseling improved PA among breast cancer
patients at 3 and 6 months and also differentially improved
patients’ motivational readiness at all follow-ups,

suggesting the potential for exercise promotion in cancer
follow-up care.
Keywords: breast cancer, physical activity, exercise, counseling
Supplemental materials:
http://dx.doi.org/10.1037/a0029886.supp
A growing number of cancer survivors face impairments in
physical functioning, increased fatigue and reduced quality of
life
(QOL), and increased risk for cardiovascular disease, obesity,
osteoporosis and future cancers (Institute of Medicine and the
National Research Council, 2006). Evidence suggests that
partic-
ipating in moderate-intensity physical activity (PA) for at least
three months improves physical functioning, QOL, and mood
and
reduces fatigue among cancer survivors (Agency for Healthcare
Research and Quality, 2004; Galvão & Newton, 2005; Knols,
Aaronson, Uebelhart, Fransen, & Aufdemkampe, 2005; Speck,
Courneya, Masse, Duval, & Schmitz, 2010). Cancer treatments
require frequent follow-up appointments that provide oncology
health care providers (HCPs) with opportunities to encourage
patients to change health risk behaviors. However, Sabatino and
colleagues (2007) found that only 25% of a national sample of
cancer survivors reported receiving a recommendation about ex-
ercise from their physicians.
HCPs have played a minimal role, if any, in PA interventions
for
cancer patients. One study involved breast cancer patients seen
at
adjuvant treatment consultation. Participants received either: a)
a

recommendation to exercise, b) a recommendation plus a
referral
to an exercise specialist, or c) usual care (Jones, Courneya,
Fairey,
& Mackey, 2004). PA assessments at 1 and 5 weeks revealed
greater PA participation in the group that received a recommen-
dation to exercise versus usual care. In our trial, HCPs were
asked
to provide PA advice to patients who had completed surgery and
adjuvant chemotherapy/radiation. Evidence suggests that it is
not
practical to rely on physicians to provide more intensive
interven-
Bernardine M. Pinto, Centers for Behavioral and Preventive
Medicine,
The Miriam Hospital, Providence, Rhode Island, and W. Alpert
Medical
School of Brown University; George D. Papandonatos, Center
for Statis-
tical Sciences, Brown University; Michael G. Goldstein, Office
of Patient
Care Services, VHA National Center for Health Promotion and
Disease
Prevention, Durham, North Carolina.
This research was funded by a grant from the American Cancer
Society
and Rays of Hope (RSGPB-03-243-01 PBP). We gratefully
acknowledge
the contributions of the research staff (Susan Abdow, Stephanie
Berube,
Christopher Breault, Jennifer Correia, Kelly Greenwood, and
Joyce Lee).
We thank the physicians who participated in the study and
assisted with

patient recruitment. The trial is registered in the Clinical Trials
Registry
(NCT 002 30711).
Correspondence concerning this article should be addressed to
Bernar-
dine M. Pinto, Centers for Behavioral and Preventive Medicine,
The
Miriam Hospital, One Hoppin St., Coro Bldg., Suite 314,
Providence, RI
02903. E-mail: [email protected]
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Health Psychology © 2013 American Psychological Association
2013, Vol. 32, No. 6, 616 – 626 0278-6133/13/$12.00 DOI:
10.1037/a0029886
616
http://dx.doi.org/10.1037/a0029886.supp
mailto:[email protected]
http://dx.doi.org/10.1037/a0029886
tions, and that instead we should involve nonphysician staff
such
as telephone counselors (Marcus et al., 1998) and incorporate

interactive health technology (de Vries & Brug, 1999) in our
interventions. Hence, we extended brief HCP advice with a
3-month telephone counseling program for PA.
The use of telephone-based interventions to promote PA in a
general population has been well documented (see reviews by
Castro & King, 2002; Eakin, Lawler, Vandelanotte, & Owen,
2007; Goode, Reeves, & Eakin, 2012). The studies reviewed
showed convincingly that such interventions are not only effica-
cious, but they also offer unique advantages of increased conve-
nience and access. There are also increased opportunities for
contact anywhere a telephone is accessible and increased time
efficiency. These advantages, together with the counselor’s
skills
and resources, can help promote PA among individuals who may
not be receptive to face-to-face contact or printed materials.
Telephone-based PA interventions over 6 –12 weeks have been
tested among small samples of breast cancer patients (Matthews
et
al., 2007; Mock et al., 1997) with positive effects on PA (Mat-
thews et al., 2007) and reductions in patients’ anxiety, fatigue,
and
sleeping difficulties (Mock et al., 1997). Telephone calls have
also
been used in PA interventions offered over 6 months and longer
to
breast, prostate, and other cancer survivors (Bennett, Lyons,
Winters-Stone, Nail, & Scherer, 2007; Demark-Wahnefried et
al.,
2006; Morey et al., 2009) with one study showing favorable
effects
at the end of a 6-month intervention (Bennett et al., 2007) and
another study with a 12-month intervention showing significant
group effects on PA and physical functioning (Morey et al.,
2009).
In sum, there is evidence to support the efficacy of telephone-

based interventions at postintervention in promoting PA among
cancer survivors. However, these PA interventions did not
involve
HCPs and a majority did not assess PA outcomes in the long-
term.
In this study, we used a telephone counseling program whose
efficacy had been previously tested among breast cancer
patients
(Pinto, Frierson, Rabin, Trunzo, & Marcus, 2005) to extend the
HCP advice. The comparison group also received HCP advice
and
telephone calls to control for contact as a more conservative test
of
the intervention. In addition, final assessment of outcomes oc-
curred 6 months after all intervention contact ended.
The primary purpose of this study was to examine the effects of
HCP advice to become physically active plus Telephone
Counsel-
ing (Intervention) versus HCP advice plus Contact Control
(Con-
trol) on self-reported minutes of PA (leisure and occupational
activity) of at least moderate-intensity at 3 months among
women
who had completed breast cancer treatment. We hypothesized
that
extending brief HCP advice by providing telephone counseling
specific to PA would produce stronger increases in PA at 3
months
than telephone contact of the same frequency that provided
health
monitoring. Secondary aims included examining maintenance of
intervention effects on PA at 6 and 12 months. We also
hypothe-
sized that the increased PA among intervention participants
would

maintain over time. Other goals included examining
intervention
effects on the proportion of participants who met PA guidelines
and on participants’ motivational readiness for PA at 3 months,
6
months, and 12 months. We hypothesized that a larger
proportion
of intervention participants would meet PA guidelines, and that
the
intervention group would progress further in motivational readi-
ness for PA. Finally, we sought to examine intervention effects
on
self-reported physical functioning and fatigue at follow-up. We
hypothesized that the intervention group would report improved
physical functioning and reduced fatigue at follow-ups
compared
with the control group.
Methods
Design
We conducted a randomized trial offering all participants HCP
advice for PA and then compared: (a) 12 weeks of additional
Telephone Counseling, and (b) Contact Control. Assessments
were
conducted at baseline, posttreatment (3 months), at 6 months
and
12 months. Institutional Review Boards at the Miriam Hospital
and
Women and Infants Hospital approved the study. The study was
conducted in accordance with the Helsinki Declaration from
2004 –2009.
Recruitment

Participants were recruited by informational letters sent by
oncologists and surgeons to their patients, and by in-person re-
cruitment at a hospital-based oncology clinic. HCPs were asked
to
review their nonurgent follow-up care schedules and to identify
women who had completed breast cancer treatment, had no
current
evidence of disease, and were expected to live � 12 months.
Letters were mailed to these patients approximately three
months
before their next visit. If patients were interested in the study,
they
were asked to contact the study staff who conducted an
eligibility
screen by telephone. Eligibility criteria: 1) female aged � 18
years, 2) completed primary and adjuvant treatment for breast
cancer (patients on hormone treatment such as Tamoxifen were
eligible), 3) � 5 years since treatment completion, 4) able to
read
and speak English, 5) provided consent for medical chart
review,
6) able to walk unassisted, 7) were relatively inactive (�30 min/
week of vigorous-intensity exercise or �90 min/week of
moderate-intensity exercise), and 8) had access to a telephone.
Participants were excluded if they had a prior history of cancer
or
if they had a medical or current psychiatric illness (e.g., cardio-
vascular disease, diabetes) that could hinder compliance with
the
study protocol.
We completed 351 initial telephone screens to determine study
eligibility (see Figure 1). Of those screened, 192 (54.7% of
phone
screens, 71% of eligible respondents) were eligible, interested,

and
eventually randomized. The study was designed to have 80%
power to detect a between-groups difference in change scores of
0.35 SD units at the 5% level of significance, based on cross-
sectional comparisons at 3 months. Due to recruitment
difficulties,
the study goal of 300 based on N � 125/group at 3 months
(starting from N � 150/group at baseline) could not be met
within
the time available. Based on 83 control and 88 intervention par-
ticipants with valid 7-day physical activity recall (PAR)
measures
at 3 months (see Figure 1), the minimum detectable between-
groups difference in change scores rose to 0.42 SD units. Given
the
observed 3-month change-score SD of 106 min/week, this trans-
lates to a 45-min difference in 3-month change scores, before
taking into account the additional power offered by the repeated
measures design.
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617PHYSICAL ACTIVITY INTERVENTION
Procedure

After providing informed consent, participants obtained medical
clearance from their oncologist. All participants received PA
ad-
vice from an oncologist/surgeon during a clinic visit (n � 100)
or
advice documented in a letter (n � 92) after they were referred
for
study participation during a clinic visit. After receiving HCP
advice, they were randomly assigned to the two study arms
using
a centrally administered randomization procedure that stratified
on
prior chemotherapy status (yes/no) and PA level (participants
classified as active vs. not based on a PA threshold of 30 min/
week). HCPs and staff conducting the assessments were blinded
to
participants’ group assignments. Participants and intervention
co-
ordinators were not blinded to group assignments.
HCP Advice
Oncologists and surgeons (n � 14, 29% women, mean years in
practice � 15.6, SD � 8.9, mean age � 50.8, SD � 9.6) at three
local hospitals and two private practices who were invited to
participate in the study received training (15–30 min) in
providing
brief PA advice (�5 min). The brief motivational counseling
protocol was derived from the 5As counseling strategy (address
the agenda, assess, advise, assist and arrange follow-up) used
previously for training physicians (Goldstein et al., 1999; Pinto,
Goldstein, Ashba, Sciamanna, & Jette, 2005). The HCP’s role
was
to provide patients a brief message about PA benefits,

recommend
30 min of moderate-intensity PA on most days of the week, and
arrange for follow-up with study staff.
Participants who were recruited via informational letters re-
ceived HCP advice at the next regularly scheduled clinic visit.
At
this visit, providers were cued by prompts placed on patients’
charts to deliver PA advice. Documentation of message delivery
was recorded on the chart prompt. Providers were allowed to
drop
patients from the study if the goal of moderate-intensity PA
would
be unsafe for the patient. After completing the clinic visit, each
participant was met by research staff, the chart prompt was col-
lected and her randomization status was determined. For partici-
pants recruited on-site (n � 92), HCPs recommended the study
to
patients seen in clinic. If interested, eligible and enrolled in the
study, the participant was given a letter from her HCP
document-
Initial phone screen for eligibility, n=351
Ineligible: 23.1% (n=81)
Too active=36
Medical issues=16
>10 years postdiagnosis=2
Ongoing psychological issues=3
No English fluency=2
Not able to exercise= 3
Enrolled in another study=6
HCP not participating=1
Other=12
Eligible at phone screen: 76.9% (n=270)

Eligible and randomized: 71.1% (n=192)
Not randomized: 28.9% (n=78)
No interest=18, Too busy=18
Lost contact=8, Family issues=5
Medical issues=4, Other reason=11
Reason unknown=14
TC Group (n=106) CC Group (n=86)
12-week PA Counseling 12-week Contact
Post-treatment assessment: 83.9% (n=89)
Attrition=17 (Lost contact=8, family issues=4,
cancer=2, no interest=2, too busy=1)
Primary outcome analyzed: 83.0% (n=88)
Post-treatment assessment: 97.6% (n=84)
Attrition=2 (Lost contact=2)
Monthly PA calls for 3 months
Monthly calls for 3 months
Oncology HCP advice
(in-person or by letter)
Assessment at 6 months: 81.1% (n=86)
Attrition=3 (Lost contact=1, family issues=1, no interest=1)
Attrition=4 (No interest=2, too busy=1, surgery=1)

Attrition=2 (Lost contact=1, cancer=1)
Attrition=2 (too busy=1, death=1)
Figure 1. Flow diagram of participant recruitment,
randomization, and retention.
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618 PINTO, PAPANDONATOS, AND GOLDSTEIN
ing “brief advice” elements (advise, assist and arrange follow-
up/
referral to study staff) and randomized. Advice documented in a
letter was used to reduce delays in study enrollment since the
next
clinic visit may have been more than 3 months later.
HCP Advice Plus Telephone Counseling (Intervention)
These participants received in-person instructions on how to

exercise at a moderate-intensity level, monitor heart rate, and
how
to warm up before and cool down after PA. They were given
home
logs to monitor PA participation and a pedometer (Digiwalker,
Yamax Corporation, Tokyo, Japan). The intervention was
individ-
ualized to the participant’s baseline PA (and motivational readi-
ness) such that, inactive participants were encouraged to be
phys-
ically active for at least 10 min on at least 2 days/week (these
goals
were higher for those who were physically active at baseline),
and the
goals were gradually increased over the 12 weeks to 30 min/day
on at
least 5 days/week (U.S. Department of Health and Human
Services,
1996). For participants who reported some level of PA at
baseline, the
exercise goals negotiated by the interventionist were higher.
Hence,
starting points and rates of PA progression varied across
participants
because these were individualized to increase the motivation
and
confidence of the participants. The counseling promoted
moderate-
intensity aerobic PA at 55– 65% maximum heart rate such as
brisk
walking, biking, or swimming.
Each participant received eight telephone calls over 12 weeks
(weekly for 4 weeks, biweekly for 8 weeks) from Intervention
Coordinators to support PA adoption. Counseling was based on
the

Transtheoretical Model and Social Cognitive Theory (Bandura,
1986; Prochaska & DiClemente, 1983), and it was tailored to
each
participant’s motivational readiness (Marcus & Simkin, 1993).
The counseling focused on strengthening self-efficacy for PA,
and
it trained participants in techniques such as self-monitoring of
PA,
setting PA goals, and planning for exercise. Cognitive processes
of
change were emphasized for participants in Contemplation, and
behavioral processes were emphasized for those in Preparation
(Marcus & Simkin, 1993). Specific components from
motivational
interviewing (conviction of the importance of PA to cancer
recov-
ery and confidence in becoming/staying active) were also
assessed
during the calls.
The PA counseling followed a structured format covering the
following topics: assessment of the past week’s PA (and
motiva-
tional readiness), assessment of health problems, exploration of
barriers to PA, assessment of the participant’s conviction of the
importance of PA, negotiation of PA goals for the following
week(s), assessment of the participant’s confidence in achieving
the goals, and review of the tip-sheets that were sent to the
participant. If participants reported physical symptoms such as
chest pain, they were referred to their physician for clearance to
resume study participation.
Participants were mailed a PA and a cancer survivorship
tip-sheet on topics such as body image, each week over the
12-week intervention. Finally, a letter summarizing the partic-
ipant’s progress was sent to her at weeks 2, 4, 8, and 12. After

the 3-month assessments were completed, monthly phone calls
over the next 3 months were provided to reinforce regular PA
and prevent lapses.
HCP Advice Plus Contact Control Group (Control)
These participants received eight calls over 12 weeks (weekly
for 4 weeks, biweekly for 8 weeks) during which the Symptom
Questionnaire (Winningham, 1993) was administered to monitor
problems such as headaches. Interventionists were trained not to
discuss PA with this group. If the participants reported PA, the
interventionist listened but did not provide any counseling
related
to PA. The goal was to match contact frequency with the inter-
vention group, with no attempt made to match call duration
across
groups. In addition, participants received cancer survivorship
tip-
sheets. After the 3-month assessment, they also received
monthly
phone calls for 3 months, during which the Symptom Question-
naire was administered.
Intervention Delivery
All telephone calls to study participants were audio-taped, and
25% of these tapes were randomly selected for review by the
principal investigator and a co-investigator to ensure fidelity to
protocol. In addition, participant issues were discussed during
weekly staff meetings.
Measures
Disease and treatment variables (from medical records) and
demographic information were obtained at baseline. At baseline
and subsequent assessments, body weight and height were mea-

sured. Participants received small incentives (e.g., $10 gift
cards)
for completing the assessments which included:
Seven-Day Physical Activity Recall (7-day PAR;Blair et al,
1985). This interviewer-administered measure (Sallis et al.,
1985; Sarkin, Campbell, & Gross, 1997) assesses hours spent in
sleep as well as moderate, hard, and very hard activity (leisure
and
occupational) over the past week. We were interested in the
weekly minutes of at least moderate-intensity PA, which we
ana-
lyzed as a continuous outcome (primary outcome) and as a
dichot-
omous indicator of whether participants met recommendations
(U.S. Department of Health and Human Services, 1996) of at
least
150 min/week of moderate-intensity PA.
Stage of Motivational Readiness for PA (Marcus, Rossi,
Selby, Niaura, & Abrams, 1992). This reliable and valid mea-
sure assesses an individual’s motivational readiness for PA
(Mar-
cus & Simkin, 1993). It classifies individuals into one of five
stages: precontemplation (individuals who do no PA and do not
intend to start), contemplation (those who do not participate in
PA
but intend to start), preparation (those who participate in some
PA
but not regularly), action (those who currently participate in
reg-
ular activity, but have done so for less than 6 months), and
maintenance (those who have participated in regular PA for 6
months or longer). For the purposes of this study, regular PA
was
defined as at least 30 min of moderate-intensity exercise on � 5

times per week. Since movement into Action/Maintenance has
been significantly associated with fitness improvements
(Marcus
& Simkin, 1993), we modeled motivational readiness as
dichoto-
mous, contrasting those who successfully transitioned into
Action/
Maintenance with those that did not.
MOS 36-Item Short Form Health Survey (SF-36; McHor-
ney, Ware, & Raczek, 1993; Ware & Sherbourne, 1992). This
assesses eight health concepts (e.g., physical functioning,
bodily
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pain). We used the Physical Functioning subscale (PF), as
cancer
survivors who adopted exercise have shown improvements on
this
subscale (Pinto, Trunzo, Reiss, & Shiu, 2002). This measure
yields
a continuous variable that ranges from a low score of 0

(limitations
in physical activities) to a high score of 100 (no limitations).
Functional Assessment of Cancer Therapy Scale-Fatigue
(FACT-F). This 13-item scale is a brief, reliable, and valid
measure of the physical and functional effects of fatigue. It has
strong internal consistency, and it shows a significant positive
relationship with other measures of fatigue (Yellen, Cella, Web-
ster, Blendowski, & Kaplan, 1997). Scores on this measure
range
from 6 (high fatigue) to 52 (low fatigue).
Analyses
T tests for continuous variables and �2 tests for categorical
variables were used to examine the success of the randomization
procedure in balancing participants’ characteristics, including
baseline values of the outcomes of interest (see Table 1).
Similar
analyses were used to compare retained participants versus
drop-
outs.
Longitudinal trajectory modeling of continuous outcomes was
conducted using Linear Mixed Effects (LME) models, as imple-
mented in Splus 8.2 (Insightful Corporation, 2007). Mean
change
scores from baseline were adjusted for baseline values of each
outcome, and they were calculated separately by treatment
group
at each follow-up. Any variables showing significant between-
groups differences at baseline were also included as potential
confounders. Subject-specific random intercepts were used to
ac-
commodate within-subject correlation across time.

Of note, LME models employ likelihood-based estimation pro-
cedures that use all available data to produce consistent
estimates
of the regression coefficients (Daniels & Hogan, 2008; Little &
Rubin, 2002). Although they remain sensitive to drop out
patterns
that depend on the missing outcome itself, they are superior to
completers-only analyses or intention-to-treat approaches that
as-
sign a prespecified score to the missing data.
Longitudinal binary outcomes were analyzed using Generalized
Estimating Equation (GEE) methodology, as implemented in the
Correlated Data Library of Splus 8.2 (Insightful Corporation,
2007). Logistic regression models with a working independence
correlation matrix were used to estimate the effect of baseline
PA
levels and study arm on the odds of meeting or exceeding PA
guidelines at each follow-up (U.S. Department of Health and
Human Services, 1996, 2008). A similar GEE procedure was
used
to analyze movement into Action/Maintenance by study arm,
controlling for stage of change at baseline (Contemplation vs.
Preparation).
Results
Sample Characteristics
As seen in Table 1, 192 women (mean age � 60.0 years, SD �
9.9, mean time since diagnosis � 2.9 years, SD � 2.1) were
assigned to either intervention (n � 86) or control (n � 106),
using
a stratified randomization scheme. Overall, 22 intervention and
eight control participants withdrew or were dropped from the
trial

(see Figure 1). Attrition in the control group was consistently
low
across time, whereas the intervention group experienced higher
dropout at 3 months (n � 17), and limited losses thereafter.
Within-group comparisons in the intervention arm, in terms of
baseline characteristics, showed that 26% of dropouts had a
mas-
tectomy at 3 months versus 12% of retained participants (p �
.1).
Two participants sustained minor injuries related to falling off a
treadmill, and one died during the trial for reasons unrelated to
study participation.
Analyses revealed no statistically significant between-groups
differences on demographic variables or outcomes at baseline.
However, intervention versus control differences in
chemotherapy
rates (55% vs. 66%) and full-time employment (FTE) status
(55%
vs. 47%) were deemed meaningful enough to warrant further
examination of these variables as potential confounders of the
treatment-outcome relationship. Results suggested that
chemother-
apy did not affect any outcome of interest. However, FTE status
affected all outcomes other than fatigue, at least during the 12-
week intervention period. Therefore, longitudinal trajectories of
study participants were adjusted not only for baseline values of
each outcome, but also for FTE status, where warranted.
PA Outcomes
Seven-day PAR. Intervention participants outperformed con-
trol participants by about 30 min/week of at least moderate
inten-
sity PA at both 3 months (p � .048) and 6 months (p � .032),

but
this beneficial telephone counseling effect dissipated at 12
months
(p � .574). For illustrative purposes, we also included in Table
2
covariate-adjusted intervention and control change score
trajecto-
ries for a reference group of participants not in FTE with
baseline
PA levels set at the overall sample mean (45 min/week). These
can
be combined with the reported baseline PA and FTE effects to
construct anticipated PA trajectories for any study participant of
interest. For every additional hour by which a participant’s
base-
line PA level exceeded the sample mean, anticipated PA
increases
at follow-up were reduced in both study arms by 16 min at 3
months (p � .03), 35 min at 6 months (p � .001), and 28 min at
12 months (p � .001). In addition, FTE status increased weekly
PA levels by 46 min at 3 months (p � .002), but its effect was
attenuated at both 6 months (p � .604) and 12 months (p �
.643).
Meeting PA guidelines. Given the sensitivity of average PA
levels to the presence of outliers, we also estimated a logistic
regression model in which the binary response was an indicator
of
whether a participant was able to meet or exceed guidelines of
150
min/week of PA at follow-up (U.S. Department of Health and
Human Services, 2008). Results in Table 3 suggest beneficial
intervention effects at 3 months (OR � 2.43, p � .016) and 6
months (OR � 2.11, p � .05), but not at 12 months (OR � 1.16,
p � .704) for a reference group of participants not in FTE
report-

ing mean PA levels at baseline. As expected, higher PA at study
entry made it even more likely that a participant would succeed
in
meeting guidelines at follow-up: For every hour by which a
participant’s baseline PA exceeded the sample mean of 45 min/
week, the odds of meeting guidelines at follow-up rose by 11%
to
23% across study arms, depending on time point. Finally, FTE
status more than doubled the odds of meeting guidelines at 3
months (OR � 2.33, p � .02), but its effect was attenuated at
both
6 months (p � .366) and 12 months (p � .477).
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Table 1
Sample Characteristics at Baseline (N � 192)
Characteristic/Category
Groupsa
CC (n � 86) TC (n � 106)

p-valueNo. % No. %
Race/Ethnicity
Non-Hispanic White 80 93 100 95 .79
Non-Hispanic Black 4 5 3 3
Hispanic 2 2 2 2
Marital status
Single 7 8 6 6 .81
Married/Living with partner 59 69 79 75
Divorced/Separated 12 14 12 11
Widowed 8 9 9 8
Employment status
Employed full-time 47 55 50 47 .27
Employed part-time 10 12 20 19
Unemployed 4 5 8 8
Retired 20 24 18 17
Homemaker/Medical leave 4 5 10 9
Educational level
High School Diploma 16 19 19 18 .99
Vocational/Trade School 5 6 6 6
Some college 24 28 28 26
Associate Degree 10 12 11 10
Bachelor Degree 14 16 20 19
Graduate School 17 20 22 21
Household income
Less than $29,999 8 10 13 13 .39
$30,000–$39,999 7 9 11 11
$40,000–$49,999 15 19 10 10
Over $50,000 49 62 63 65
Age in years

Mean (SD) 55.9 (9.9) 56.1 (9.9) .89
Body mass index
Mean (SD) 28.7 (5.1) 29.6 (6.2) .28
Cancer stage
0 12 14 12 11 .89
I 33 38 41 39
II 34 40 44 42
III/IV 7 8 9 8
Cancer treatmentb
Lumpectomy 66 77 76 73 .68
Lumpectomy with dissection 44 51 53 50 .96
Mastectomy 28 33 34 33 .91
Mastectomy with reconstruction 6 7 6 6 .95
Radiation 63 73 76 72 .94
Chemotherapy 47 55 69 66 .16
Hormone treatment 70 81 78 74 .32
Years since diagnosis
Mean (SD) 2.9 (2.1) 3.0 (2.2) .72
Motivational readiness
Contemplation 67 78 81 76 .13
Preparation 13 15 23 22
Action/Maintenance 6 7 2 2
PA guidelines
�150 PAR min/week 79 92 100 94 .70
�150 PAR min/week 7 8 6 6
7-day PAR (min/week)
Mean (SD) 46.8 (62.5) 42.9 (59.4) .67

FACT-F
Mean (SD) 38.1 (11.6) 39.3 (9.9) .47
SF-36 PF
Mean (SD) 72.8 (22.8) 77.2 (19.5) .15
Note. TC � Telephone Counseling; CC � Contact Control; PA
� Physical Activity; PAR � 7-day PAR; FACT-F � Functional
Assessment of Cancer
Therapy Scale-Fatigue; SF-36 PF � MOS 36-Item Short Form
Health Survey: Physical Functioning subscale.
a Percentages have been calculated on cases with available data.
b Each patient may have received more than one treatment;
percentages do not add to
100.
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Motivational readiness. All but eight participants were in
either the Contemplation or Preparation stage at study entry,
and a
secondary study goal was to move them (N � 184) to Action or
Maintenance stage at follow-up (Prochaska & DiClemente,

1983).
Telephone counseling appears to have produced long-lasting ef-
fects on motivational readiness among a reference group of par-
ticipants not in FTE that joined the study while in
Contemplation:
As seen in Table 3, such participants were much more likely to
have reached Action/Maintenance at 3 months (OR � 4.45, p �
.001) and 6 months (OR � 3.93, p � .003) if assigned to the
intervention than the control arm, and these intervention effects
were strengthened further at 12 months (OR � 6.28, p � .001).
Participants entering the study in Preparation were significantly
more likely to move to Action/Maintenance than those in
Contem-
plation, whether at 3 months (OR � 3.76, p � .002), 6 months
(OR � 2.57, p � .033), or 12 months (OR � 2.64, p � .041). In
contrast, FTE status more than doubled the odds of reaching
Action/Maintenance at 3 months (OR � 2.58, p � .02), but its
effect was attenuated at both 6 months (p � .373) and 12
months
(p � .725).
Table 2
Point Estimates and 95% Confidence Intervals for Change
Scores From Baseline to Follow-Upa
Outcome/Group
Follow-up
3 Months 6 Months 12 Months
Mean 95% CI Mean 95% CI Mean 95% CI
7-day PAR (min/week)
TC 59.70 (35.59, 83.80) 56.64 (32.22, 81.07) 44.06 (19.22,

68.89)
CC 30.82 (5.13, 56.51) 24.48 (�1.43, 50.40) 35.61 (9.04, 62.17)
TC vs. CC 28.88 (0.44, 57.32) 32.16 (3.06, 61.26) 8.45
(�20.95, 37.86)
Baseline PARb �15.83 (�30.36, �1.30) �35.25 (�49.85,
�20.64) �27.76 (�42.40, �13.13)
FTE vs. not 46.10 (17.67, 74.52) 7.70 (�21.34, 36.73) �6.96
(�36.32, 22.41)
SF-36 PF
TC 3.73 (�0.39, 7.86) 4.79 (0.64, 8.95) 3.87 (�0.32, 8.06)
CC �2.74 (�7.14, 1.65) 1.09 (�3.42, 5.59) 1.11 (�3.40, 5.62)
TC vs. CC 6.48 (1.60, 11.35) 3.71 (�1.27, 8.69) 2.76 (�2.26,
7.77)
Baseline SF-36 �0.40 (�0.52, �0.29) �0.35 (�0.46, �0.23)
�0.35 (�0.47, �0.23)
FTE vs. not 6.49 (1.60, 11.38) 4.08 (�0.93, 9.09) 1.75 (�3.29,
6.80)
FACT-F
TC 4.53 (2.88, 6.18) 3.84 (2.17, 5.51) 3.69 (1.98, 5.39)
CC 3.41 (1.70, 5.13) 1.95 (0.18, 3.72) 1.44 (�0.31, 3.20)
TC vs. CC 1.12 (�1.26, 3.50) 1.89 (�0.54, 4.33) 2.44 (�0.20,
4.69)
Baseline FACT-F �0.40 (�0.51, �0.29) �0.37 (�0.48, �0.26)
�0.40 (�0.51, �0.29)
Note. TC � Telephone Counseling; CC � Contact Control; FTE
� Full-time employment; PAR � 7-day PAR; SF-36 PF � MOS
36-Item Short Form
Health Survey Physical Functioning subscale; FACT-F �
Functional Assessment of Cancer Therapy Scale-Fatigue.
a Boldface estimates denote p-values significant at � � .05. b
Baseline PAR expressed in hours/week.
Table 3

Longitudinal Logistic Regression Models Predicting
Achievement of PA Guidelines and Movement to
Action/Maintenance at Follow-Upa
Outcome/Coefficientb
Follow-up
3 Months 6 Months 12 Months
OR 95% CI OR 95% CI OR 95% CI
PA guidelines
TC 0.43 (0.23, 0.82) 0.39 (0.21, 0.73) 0.33 (0.17, 0.65)
CC 0.18 (0.09, 0.35) 0.18 (0.09, 0.36) 0.29 (0.15, 0.54)
TC vs. CC 2.43 (1.18, 4.98) 2.11 (1.00, 4.48) 1.16 (0.54, 2.52)
Baseline PAR 1.23 (1.08, 1.39) 1.12 (1.02, 1.23) 1.11 (1.03,
1.19)
FTE vs. not 2.33 (1.14, 4.76) 1.41 (0.67, 2.98) 0.76 (0.35, 1.63)
Action/Maintenancec
TC 0.27 (0.13, 0.57) 0.28 (0.14, 0.59) 0.35 (0.16, 0.74)
CC 0.06 (0.02, 0.15) 0.07 (0.03, 0.19) 0.06 (0.02, 0.15)
TC vs. CC 4.45 (2.02, 9.80) 3.93 (1.57, 9.80) 6.28 (2.29, 17.24)
Prep. vs. Con 3.76 (1.59, 8.86) 2.57 (1.08, 6.14) 2.64 (1.04,
6.70)
FTE vs. not 2.58 (1.16, 5.74) 1.45 (0.64, 3.26) 1.16 (0.50, 2.70)
Note. TC � Telephone Counseling; CC � Contact Control; FTE
� Full-time employment; Con � Contemplation; Prep. �
Preparation; PA � Physical Activity;
PAR � 7-day PAR.
a Boldface estimates denote p-values significant at � � .05. b
Baseline PAR expressed in hours/week. c Model estimated
among N � 184 participants

in Contemplation or Preparation at study entry.
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Psychosocial Outcomes
Physical functioning. Intervention participants outperformed
control participants by 6.48 units on the SF-36 PF scale at 3
months (p � .01), but group differences narrowed at 6 months
(p � .147) and 12 months (p � .497). Table 2 displays
covariate-
adjusted intervention and control change score trajectories for a
reference group of participants not in FTE reporting with
average
SF-36 levels at baseline (75.21 units). Trajectories for other
study
participants can be constructed by noting that for every
additional
unit by which a participant’s baseline SF-36 score exceeded the
sample mean, anticipated SF-36 PF increases in both study
groups
were reduced by 0.35– 0.40 units at follow-up across study arms
(all ps � .001). In addition, FTE status increased physical func-

tioning by 6.49 units at 3 months (p � .01), but its effect was
attenuated at both 6 months (p � .112) and 12 months (p �
.497).
Fatigue. No significant group differences in fatigue levels
were found at follow-up. Illustrative intervention and control
change score trajectories are depicted in Table 2 for a reference
group of participants not in FTE reporting mean FACT-F scores
of
38.76 units at baseline. Trajectories for other participants can
be
calculated by noting that for every additional unit by which a
participant’s baseline FACT-F score exceeded the sample mean,
anticipated FACT-F increases in both study groups were
reduced
by 0.37– 0.40 units at follow-up (all ps � .001).
Intervention Delivery
The proportion of participants receiving in-person HCP advice
was balanced across study arms, with negligible intervention
ver-
sus control differences (51.12% vs. 52.83%, p � .93). In-person
HCP advice, as evidenced by completed chart prompts, was de-
livered to 98% of the participants who received in-person
advice
(mean duration of advice � 4.7 min, SD � 1.4). Eighty-six
percent
of the participants reported that their HCPs explained the health
benefits of PA, and 96% were satisfied with the advice. During
the
3-month intervention phase, a mean of 6.7 calls (SD � 1.81)
were
delivered to intervention participants and 7.1 calls (SD � 1.3)
to
control participants (p � .07; max. possible � eight calls). As

expected, calls in the intervention arm were of longer duration
(M � 15.0 min, SD � 5.8) than calls in the control arm (M �
9.0
min, SD � 3.9, p � .001).
Discussion
Our primary goal was to examine the effects of HCP advice plus
Telephone Counseling (Intervention) versus HCP advice plus
Con-
tact Control (Control) on participants’ PA at 3 months. HCPs
were
able to provide brief exercise advice, which the participants
found
satisfactory. We found that intervention participants
outperformed
control participants by about 30 min/week of at least moderate
intensity PA at 3 months and 6 months, but that this effect
dissipated at 12 months. In practical terms, this translates to PA
increases of one additional day/week in terms of USDHHS
guide-
lines (U.S. Department of Health and Human Services, 2008)
that
recommend moderate-intensity PA of at least 30 min/day on
five
or more days/week, or a minimum of 150 min/week overall.
Results were consistent across continuous and binary measures
of
PA (average 7-day PAR levels vs. proportion meeting PA guide-
lines of 150 min/week), which is reassuring, since the former
can
be susceptible to the influence of outliers.
On motivational readiness for PA, the outcome most closely
related to the theoretical basis underlying the intervention, we

found strong intervention effects that were maintained
throughout
the 12-month study period. In particular, intervention
participants
outperformed control participants in terms of moving from Con-
templation/Preparation at study entry to Action/Maintenance at
follow-up, a change in motivational readiness previously associ-
ated with fitness improvements (Marcus & Simkin, 1993). The
apparent discrepancy in the strength of intervention effects on
self-reported PA levels and on motivational readiness for PA at
12
months may be due to differences over the reference assessment
period (the previous week in the PAR vs. the previous 6 months
for
moving to the Action/Maintenance stage of motivational
readiness
for PA). As PA levels were elevated in the intervention group at
6
months relative to 12 months, motivational readiness at 12
months
may be capturing PA increases at the previous assessment point
not included in the 7-day PAR administered at 12 months.
The only other known study in which HCPs provided PA advice
to breast cancer patients, had effects assessed at 1 and 5 weeks
(Jones et al., 2004), so it is difficult to compare the results
across
studies, but it is clear that our study—which followed patients
for
much longer—found positive effects of HCP advice plus
telephone
counseling on PA at 3 months and 6 months. When considering
telephone-based interventions and short-term effects (3
months),
stronger effects on PA were found in our previous 12-week tele-
phone counseling intervention among breast cancer patients

(Pinto,
Frierson, et al., 2005). Significant effects on PA were also
found in
previous telephone counseling studies among breast cancer pa-
tients at 6 weeks (Mock et al., 1997) and at 12 weeks (Matthews
et al., 2007). In studies using other intervention approaches
such as
the effects of exercise recommendations alone, print materials
alone, pedometers alone, and a combination of print materials
and
pedometers among breast cancer survivors (Vallance, Courneya,
Plotnikoff, Yasui, & Mackey, 2007), larger group differences
(39
to 57 min/week across groups) were found at 3 months. When
considering PA outcomes at 12 months, a group difference of 13
min was achieved in a sample of 641 overweight, older long-
term
cancer survivors who received a 12-month PA and dietary inter-
vention via telephone and print materials or a delayed
intervention
(Morey et al., 2009). These interventions did not involve the
HCP,
and overlooking the HCP may present a missed opportunity for
supporting a healthy behavior such as exercise.
It is clear that the significant intervention effects in helping
breast cancer survivors meet PA guidelines at 3 months and 6
months dissipated at 12 months. One call/week over 12 weeks
had
produced significant increases in PA in a prior study among
breast
cancer survivors (Pinto, Frierson, et al., 2005). We had reduced
the
number of calls to eight in this trial which may account for
weaker
effects. Another explanation is that the inability to detect

between-
groups differences was driven by the increased PA reported by
control participants over time. Though intriguing, this increase
should not be interpreted to suggest that brief advice from HCPs
is
sufficient to increase long-term PA, because control participants
received not only HCP advice, but also similar frequency of
contact with research staff as intervention participants. This was
done to provide a more conservative test of the intervention.
However, it is possible that the contacts kept PA salient for
control
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participants and reduced the ability to detect differential
interven-
tion effects. The true test of this explanation would involve a 3-
arm
study: HCP advice plus Telephone Counseling, HCP advice plus
Contact Control, and HCP Advice alone.
Study goals included examining intervention effects on psycho-
social outcomes. Group differences in fatigue were

nonsignificant,
and the intervention effects on self-reported physical
functioning
were not maintained past 3 months. Our study participants were
not screened for high levels of fatigue and/or poor physical
func-
tioning. Mean fatigue scores at baseline were similar to those in
another PA trial for breast cancer patients initiating adjuvant
chemotherapy in which significant improvement in fatigue in
the
PA group was not found (Courneya et al., 2007). Both study
groups showed improvements in fatigue, and in the absence of a
control group that received no intervention, these results are in-
conclusive. The strength of the effect size of exercise
interventions
on cancer patients’ fatigue has been found to be inconsistent
and
highly heterogeneous across studies (0.06 –2.26), and it may be
linked to a “take all comers” approach, that is, patients in the
studies may have had low fatigue levels (Speck et al., 2010).
Similarly, our study sample’s physical functioning was high at
baseline (compared with normative data; Ware, Kosinski, &
Dewey, 2000), suggesting possible “ceiling” effects.
The higher attrition at 3 months among participants receiving
telephone counseling rather than contact control (16.1% vs.
2.3%)
was surprising (see Figure 1 for reasons), and suggests that
study
demands may have been too burdensome for some breast cancer
participants. Although higher attrition among intervention
partic-
ipants is not uncommon (Dubbert, Morey, Kirchner, Meydrech,
&
Grothe, 2008), retention was at 94% in a previous trial using
telephone counseling (12 weekly calls in a 3-month

intervention)
to promote PA among breast cancer patients (Pinto, Frierson, et
al.,
2005).
The association of working full-time and increased PA at 3
months (but not thereafter) was surprising. Finding time to
exer-
cise is often a barrier for individuals who work, and this barrier
may be stronger among women who also have household
respon-
sibilities (Dishman, 1990). But it is also possible that the
women
who worked full-time may have had better health and fewer
comorbidities than those who were not working full-time.
This study, which is one of the first to promote PA in collabo-
ration with oncology follow-up, clearly showed that motivated
HCPs were able to provide brief advice to their patients (98%
completed chart prompts). The duration of advice was brief, as
intended, and participants were generally satisfied with the
advice.
The advice was associated with short-term and long increases in
PA in both groups who received calls focusing either on PA or
contact control. The improvement in PA in the control arm was
surprising, but it may also represent the growing awareness of
the
relevance of PA for cancer recovery. Future studies may want to
test the efficacy of HCP advice in the absence of a contact
control
arm on short-term and long-term outcomes. If such studies also
focus on psycho-social effects such as fatigue and physical
func-
tioning, it is important to also recruit patients who report high
levels of fatigue and low physical functioning in order to avoid
“floor” and “ceiling” effects.

Study limitations include an actively recruited sample of pa-
tients who were able to obtain physician consent and were
willing
to be randomized. The sample was relatively homogeneous with
regard to race/ethnicity and socioeconomic status limiting the
generalizability of the findings. HCPs were asked to provide
brief
exercise advice to patients during a follow-up visit, but we were
not able to assess whether advice was provided at subsequent
follow-up visits, which may be a confounder. Another drawback
is
that the measures of PA were based on self-report. While we
included a conservative contact control group (that may have
inadvertently kept PA salient for the CC arm), there was no true
control group in the study. Finally, it is possible that additional
effects might have been detected on self-reported physical func-
tioning had the sample included women with poorer functioning
at
baseline.
Strengths of the study include a large sample size of women
within 5 years of a breast cancer diagnosis, documented
delivery of
HCP advice, use of several standardized measures of PA,
motiva-
tional readiness and psycho-social outcomes, a theoretically
based
intervention, and follow-up assessments at 6 months and 12
months. Our results show that among motivated volunteer
HCPs,
providing brief advice was feasible in the context of a follow-up
visit, and when this advice was supplemented by telephone
coun-
seling, patients’ PA participation increased for at least 6

months.
HCP advice is perceived as credible to patients and if the advice
is
kept brief and does not take valuable time from the HCP-patient
encounter, it is not likely to be burdensome in the health care
setting. While we cannot be sure that HCP advice alone would
suffice (our study design does not allow us to draw that conclu-
sion), our results suggest that the HCP advice will require
supple-
mentation to support the adoption and maintenance of PA in this
patient population. There is scope for examining whether this
type
of intervention can be implemented in large health care systems
where cancer patients are monitored for follow-up care.
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