“Barriers to enrolling patients with
ovarian cancer in clinical trials in
the state of Oregon”
Fabio Cappuccini, MD, Anale...
Enrollment in Clinical TrialsEnrollment in Clinical Trials
 In the past decade, clinical trial enrollment rates
ranged fr...
Public AttitudesPublic Attitudes
 Phone survey of 1000 American adults
showed that 32% are very willing to
participate in...
Role of the physicianRole of the physician
 Women whose primary physician advised them to
enroll were 13x more likely to ...
Barriers to Enrollment inBarriers to Enrollment in
Clinical TrialsClinical Trials
 Type of insurance coverage
 Age
 Rac...
Legislative MeasuresLegislative Measures
 National Institutes of Health Revitalization
Act of 1993
 Creation of a Minori...
ObjectivesObjectives
To identify the barriers to enrollment
onto ovarian cancer clinical trials, relying
on direct interv...
MethodsMethods
 Patients diagnosed with ovarian cancer in the
state of Oregon were indentified by the Oregon
Cancer Regis...
ResultsResults
Between 1999 and 2003, there were 1262
cases of ovarian cancer reported to OSCaR
637 – patients are alive
5...
Results - DemographicsResults - Demographics
 Mean age 60.0 yrs
 Mean age at dx 55.9 yrs
 English speaking 97.3
25.2
34...
Results continuedResults continued
Gyn Onc Ob/Gyn Gen Surgeon Other
Type of Surgeon
0
10
20
30
40
50
60
Gyn Onc Med Onc Ob...
Results continuedResults continued
Did you know about clinical
trials?
YES
NO
36
226
0
50
100
150
200
250
YES NO
Were you ...
Factors That InfluenceFactors That Influence
EnrollmentEnrollment
Desire to help future patients 18/19
Desire to advance r...
ConclusionsConclusions
Most women in Oregon with ovarian cancer
do not know about clinical trials.
Only a small percentage...
Patient QuotesPatient Quotes
“ I have always asked if there was a trial I would benefit.
The answer was no…I feel it is th...
Patient QuotesPatient Quotes
“ It is my hope that clinical studies will begin to include
older people – people in their 80...
Are we doing the right thing?Are we doing the right thing?
59%65%Education
(high school or
some college)
41.4%58.3%City of
Diagnosis
(Portland Metro)
5655.1Mean age
Not offeredOffer...
Differences BetweenDifferences Between
Accept/decline GroupsAccept/decline Groups
64.6%53%Education
(High school or
some c...
Differences between groups
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  • There is limited data as to the percentage of patients with ovarian cancer enrolled in clinical trials
    Examination of accrual to National Cancer Institute sponsored cancer treatment trials from 1988 to 1992 revealed a clear age dependent relationship to accrual.
  • Women attending either a screening clinic for breast CA/ a diagnostic clinic/ or women dx’d with breast cancer with approached with a questionnaire. Of the women who completed the questionnaire
    Range was from 25 to 36%. Women who would consider accepting had more knowledge about trials than those who wouldn’t.
  • Among patients that attended an informational session on Breast Cancer Prevention Trial,
  • Surgery performed by with gyn/onc present 62.9% of the time, by gen ob/gyn 40%, general surgeon 12.1% and by other 1.4% of the time
    Was chemotherapy discussed
    Yes129 (89.6%)No13 (9.0%)
    Gyn onc involved in this discussion 58%, medical oncologist 51%, gen ob/gyn 10%, nurse 4.6% and general surgeon 3.1% of the time
  • 44/144 (30.6%) of patient knew about clinical trials.
    Of those patients,
    Only 18 or 12.5% of patients were offered enrollment in clinical trials
  • cappuccini.ppt

    1. 1. “Barriers to enrolling patients with ovarian cancer in clinical trials in the state of Oregon” Fabio Cappuccini, MD, Analene Pentopoulos, MD Gynecologic Oncology Oregon Health & Science University Center for Women’s Health March 25, 2006
    2. 2. Enrollment in Clinical TrialsEnrollment in Clinical Trials  In the past decade, clinical trial enrollment rates ranged from 3% for breast cancer to 14% for all cancer patients.  Greater than 70% of children are enrolled, but only 1.5% of adult patients ≥ 50.2 1. Lara PN, Higdon R, Lim N, Kwan K, et al. Prospective evaluation on cancer clinical trial accrual patterns: Identifying potential barriers to enrollment. Journal of Clinical Oncology. 19(6) 2001: 1728-1733. 2.Kornblith AB, Kemeny M, Peterson BL et al. Survey of oncologists’ perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials Cancer 2002;95:989-96.
    3. 3. Public AttitudesPublic Attitudes  Phone survey of 1000 American adults showed that 32% are very willing to participate in clinical trials and an additional 38% were inclined to participate but had reservations.1  86% of respondents felt that women should be asked to participate in clinical trials, with 33% stating that they would accept participation.2 1. Comis RL et al. Public attitudez toward participation in cancer clinical trials. J Clin Oncol 2003;21:830-35. 2. Ellis PM et al. Randomized clinical trials in oncology: Understanding and attitudes predict willingness to participate. J Clin Oncol 2001;19:3554-61.
    4. 4. Role of the physicianRole of the physician  Women whose primary physician advised them to enroll were 13x more likely to participate than women whose physician advised them not to participate.1  Study looked at enrollment of patients into GOG studies at one institution. Found that more senior faculty and those that were PI for studies were more likely to offer patients enrollment and their patients were more likely to accept enrollment.2 1. Kinney AY et al. Ther effect of physician recommendation on enrollment in the Breast Cancer Chemoprevention Trial. Prev Med 1998;27:713-9 2. Mannel RS et al. Impact on individual physicians on enrollment of patients into clinical trials. Am J Clin Onco2003;26:171-3
    5. 5. Barriers to Enrollment inBarriers to Enrollment in Clinical TrialsClinical Trials  Type of insurance coverage  Age  Race  Sex  Socioeconomic status  Educational level  Type of cancer  Patient understanding of protocol  Physician’s explanation of protocol
    6. 6. Legislative MeasuresLegislative Measures  National Institutes of Health Revitalization Act of 1993  Creation of a Minority Community Clinical Oncology Program by the NCI  Focused initiatives with the Center of Disease Control and Prevention and Academic Medical Center  Increase in NCI budget from $2 billion in 1993 to $4 billion in 2002
    7. 7. ObjectivesObjectives To identify the barriers to enrollment onto ovarian cancer clinical trials, relying on direct interviews with the patient Using the State of Oregon as a model
    8. 8. MethodsMethods  Patients diagnosed with ovarian cancer in the state of Oregon were indentified by the Oregon Cancer Registry  Survey covered patient's demographic background, treatment for ovarian cancer, knowledge about and participation in clinical trials  A second survey was sent to all non-respondents after 3 weeks
    9. 9. ResultsResults Between 1999 and 2003, there were 1262 cases of ovarian cancer reported to OSCaR 637 – patients are alive 560 – surveys initially mailed 305 -- surveys have been returned 43 – declined to answer 262 – available for analysis
    10. 10. Results - DemographicsResults - Demographics  Mean age 60.0 yrs  Mean age at dx 55.9 yrs  English speaking 97.3 25.2 34.7 21.1 17.6 High School or GED Some college Bachelors Degree Graduate school 96% 2% 2% White Asian American Indian Race Education
    11. 11. Results continuedResults continued Gyn Onc Ob/Gyn Gen Surgeon Other Type of Surgeon 0 10 20 30 40 50 60 Gyn Onc Med Onc Ob/Gyn Nurse Gen Surgeon Discussion of Chemotherapy 99.3% of respondents underwent surgery Chemotherapy was discussed with 89.6% of respondents
    12. 12. Results continuedResults continued Did you know about clinical trials? YES NO 36 226 0 50 100 150 200 250 YES NO Were you offered enrollment in a trial? Of the women offered a clinical trial, 53% accepted enrollment
    13. 13. Factors That InfluenceFactors That Influence EnrollmentEnrollment Desire to help future patients 18/19 Desire to advance research 17/19 Recommendation of MD 15/19 Recommendation of family/friend 7/19 Hope for better treatment 10/19 Trial was well explained 16/19
    14. 14. ConclusionsConclusions Most women in Oregon with ovarian cancer do not know about clinical trials. Only a small percentage of women with ovarian cancer are offered enrollment in clinical trials by their physician limiting the number of women available for enrollment.
    15. 15. Patient QuotesPatient Quotes “ I have always asked if there was a trial I would benefit. The answer was no…I feel it is the responsibility of the oncologist to determine and let you know what’s out there instead of the patient asking if there is anything out there that would be of help” “ The clinical trials I am on or did consider were the result of research my husband did online…it seems the prospect of clinical trials is the responsibility of the patient”
    16. 16. Patient QuotesPatient Quotes “ It is my hope that clinical studies will begin to include older people – people in their 80’s and beyond. We would like to have the option of living longer too, if given the chance” “ In spite of a poster…saying to ask about clinical trials, I always felt that there was a pervasive strong underlying reluctance to explore the possibility”
    17. 17. Are we doing the right thing?Are we doing the right thing?
    18. 18. 59%65%Education (high school or some college) 41.4%58.3%City of Diagnosis (Portland Metro) 5655.1Mean age Not offeredOffered DifferencesDifferences
    19. 19. Differences BetweenDifferences Between Accept/decline GroupsAccept/decline Groups 64.6%53%Education (High school or some college) 53.3%63.2%City of Dx (Portland Metro) 55.956.9Mean age DeclineAccept
    20. 20. Differences between groups
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