1. Student Name(s): Giovanna Braganza
Primary Investigator: Supriya Mohile, MD
Title: Understanding Barriers to Obtaining Oral Cancer Treatment and Their Impact on Patient Cancer
Experience
Institution: University of Rochester Medical Center
Department: Geriatric Oncology
Understanding Barriers to Obtaining Oral Cancer Treatment and
Their Impact on Patient Cancer Experience
Introduction:
The benefits of oral oncolytics include their ease of use, convenience, and generally well-tolerated side effect
profiles as compared to traditional intravenous chemotherapy. Although the cost associated with oral
oncolytic therapy is high and growing, research into patient preferences and quality of life issues indicates
that patients prefer them to traditional intravenous chemotherapies. Studies evaluating adherence and oral
oncolytics show an association between out of pocket expense, social support, treatment adherence, and
treatment success. Currently there is little data describing the psychosocial impact of the financial burden
associated with oral cancer medication and its influence on patient satisfaction and medication adherence.
Objective:
Through this study we hope to:
1. Assess how financial health impacts patient satisfaction and distress during oral oncolytic treatment.
2. Measure the psychosocial burden of financial toxicity in patient undergoing oral cancer treatment.
3. Identify patient characteristics or other factors associated with patterns of treatment satisfaction.
4. Document total time and resources used by healthcare professionals in assisting patients obtain oral
cancer therapy.
Background:
Oral oncolytics are a relatively new form of anti-cancer therapy that account for roughly 25% of the oncology
drug market.1
As insurance providers devise methods of controlling their use and cost, patients are placed at
higher risk of out of pocket spending and consequently poor adherence and compliance to their cancer
treatment plans.2
Although the cost associated with cancer care and oral oncotic therapy is high and growing,
research into patient preferences and quality of life issue indicates that patients prefer oral chemotherapies
as opposed to traditional intravenous chemotherapies.3
The benefits of oral oncolytics include their ease of use, convenience, and generally well-tolerated side effect
profiles. It is important to note that because of the increased independence associated with oral oncolytic
therapy, patients require a greater level of responsibility to properly and safely administer their own oral
cancer treatments. Studies evaluating adherence and oral oncolytics show an association between

2. adherence, cost, and treatment success.4
Studies have also shown that factors such as related side effects,
out of pocket expense, and social support affect patient adherence.5
Methods:
The study population includes patients 18 years and older with solid tumor malignancy, other than breast
cancer, who are prescribed an oral oncolytic at the University of Rochester Medical Center. Study participants
are followed from the time oral cancer medication is prescribed until approximately 3 months after receipt of
medication. Details are shown in figures 1 and 2 below.
Week 1 2 4 2 4 6 8 10
Pt identifiedbyPharm/RN Staff
• Email notificationprompts enrollmentin
Study
• Complete Consent, Blessed, Call back
Form
• Give Baseline and Cover letter,and
PMRS
Day 1
D-1 2wk Visit
Pharm/GerioncStaff
• Collect complete
PMRS
• Give F/U Survery 1
w/CL
2 wks F/U
Pharm/GerioncStaff
• Collect f/u survey 1
• Give f/u survey 2 w/
CL
4-8 Wks F/U
Pharm/GerioncStaff
• Collect f/u survey 1
• Give Park voucher
10-14Wk F/U
Wkly Until
Meds
Received
Phone Survey
Every 2-4 WKS for
up to 14 WKS
Pill CountForm
Completed
Pill Count
12
Oral Chemo Timeline
GU Tumors
Reminderphone call
• Baseline survey and
Cover letter
D-1 4-8 wk Visit
Reminderphone call
• F/U survey 1
D-1 10-14wkVisit
Reminderphone call
• F/U survey 2
RX Received
Figure 1: Oral chemo study time line for GU Tumors
RX Received
Week
1
2 4 2 4 6 8
Pt identified by Pharm/RN Staff
• Email notificationprompts
enrollment in Study
• Complete Consent,Blessed, Call
back Form
• Give Baseline and Cover letter, and
PMRS
Day 1
D-1 2wk Visit
Pharm/Gerionc Staff
• Collect Baseline & complete
PMRS
• Give F/U Survery 1 w/CL
2 wks F/U
Pharm/Gerionc Staff
• Collect f/u survey 1
• Give Parking Voucher;
Study complete
4-8 Wks F/U
Wkly Until
Meds
Received
Phone Survey
Oral Chemo Timeline
All Other Tumors Reminder phone call
• Baseline survey and Cover letter
D-1 4-8 wk Visit
Reminder phone call
• F/U survey 1
Figure 2: Oral chemo study time line for All other non-GU Tumors.
As illustrated in the figures, validated patient reported outcomes tools and interviews are used to measure
the psychosocial impact of prescription wait time and to quantify financial burden, document side effect
profile, and describe patient experience while taking medication. Evaluation of medication adherence for
patients with genitourinary malignancy was done by utilizing pill counts and a comprehensive review of
medication regiment at monthly intervals.

3. Tables 1 and 2: Patient recorded outcome tools used to measure the psychosocial impact of prescription wait
time and to quantify financial burden, document side effect profile, and describe patient experience while taking
medication
Documentation of health care professional workload in assisting patients to receive oral cancer treatment is
quantified using a questionnaire.
Bivariate and multivariable analyses will be incorporated to evaluate potential associations among clinical
factors, patient reports, financial burdens, and psychosocial impacts of out of pocket costs, medication
adherence, and certain patterns for prescription wait times or certain treatment recommendations.
Results and Conclusions:
We anticipated that patients experience significant costs associated with taking oral oncolytic medications.
We also expected to find that increased cost sharing and wait time for delivery of medication would result in
higher psychosocial stress. Preliminary data however suggested that once medication is received, there is a
significant decline in worry among study participants (average baseline worry scale score of 5.2 compared to
an average follow-up worry scale score of 2.8, where 10=extremely worried) (Table 3).
Table 3. Study participant characteristicsCharacteristics Frequency
Urologic Malignancy N = 17
Non-Urologic Malignancy N= 21
Average Age 62
Work Status
Employed 9
Unemployed 21
Healthcare Provider Subjects N = 20
Baseline Worry Scale 5.2 (0-10)
PMRS Worry Scale 4.3 (0-10)
Follow-Up Worry Scale 2.8 (0-10)

4. Preliminary findings examining personal characteristics and distress display:
1. More patients with >80k reported no distress vs. distress. This association is not statistically
significant but a larger sample size might be warranted to determine correlations.
Household Income Distress
No
Distress
$0- $19,000 1 0
$20,000- $39,000 4 1
$40,000 - $59,000 4 0
$60,000 - $80,000 1 0
> $80,000 5 9
Prefer not to
answer
2 3
Total 17 13
(n=30 at baseline)
Insurance Type Mean Distress
Baseline Survey
Mean Distress PMRS
Survey
Medicare 4 5.3
Private 3.8 3.8
Grants & Patient Care Funds 3.8 4.6
Unknown/Unable to Extract 6 3
(n=26 at baseline, n=25 PMRS survey)
2. In a cohort of 26 patients, individuals with Urologic malignancies and Non-Urologic cancer paid on
average between $299-599 for oral oncolytic medications between the years of 2014 - 2016. Costs
reported were out of pocket expenses taken before insurance reimbursements and external grants
were applied.
0
1
2
3
4
5
6
7
8
$0 -$199 $200 -
$499
$500 -
$999
$1000 -
$4999
$5000 -
$9999
Frequency
Out of Pocket Expense for Oral Oncolytics
Non- GU
GU

5. 3. Patients at the Wilmot Cancer Center facility waited 0 – 37 days between the date they were
prescribed an oral oncolytic and the date the oral oncolytic medication was received. Through the
Post-Medication Receipt Survey and additional Follow-Up Surveys, patients self-reported a high
average frustration experienced while waiting for the oral oncolytics. However, patients reported
ease in finding resources to fund oral oncolytics guided by their healthcare team.
Type of Cancer
Days Waiting
for Oral
Oncolytic
Difficulty
obtaining
Oral
Oncolytic
Frustration
waiting for
Oral Oncolytic
Difficulty finding
resources to pay
for pills
Urologic Malignancy (N=17) 9.4 (0-37) 4.2 (0-10) 6.1 (0-10) 2.2
Non-Urologic Malignancy (N=21) 8.2 (0-37) 4.6 (0-10) 7.1 (0-10) 2.5
4. Data from post-medication receipt surveys revealed that increased cost sharing and wait time for
delivery of medication may be associated with higher psychosocial stress. A higher average score of
depression was reported for patients with urologic malignancies. While this study collected data on
memory, distress and depression, further analysis could be aimed to better profile risk factors,
memory loss and the cognitive side effects of oral oncolytics. Future research should further evaluate
factors associated with poor medication adherence in patients taking oral cancer medications such
as memory, mood, fatigue, and financial stress.
Type of
Cancer
Geriatric
Depression
Score(0-15)
Distress
Score(0-10)
Blessed
Score (28-0)
Satisfaction
with Cancer
Care ( 0-5)
Rating
of
Facility
( 0-5)
GU 3.8 4.6 1.9 4.4 4.4
Non-GU 2.3 4.6 2.9 4.73 4.8