Title: Barriers to enrolling patients with ovarian cancer in clinical trials in the state of Oregon
1Barriers 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 Womens
Health March 25, 2006
2Enrollment 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
200295989-96.
3Public 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 200321830-35. 2. Ellis PM et al.
Randomized clinical trials in oncology
Understanding and attitudes predict willingness
to participate. J Clin Oncol 2001193554-61.
4Role 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
- Kinney AY et al. Ther effect of physician
recommendation on enrollment in the Breast Cancer
Chemoprevention Trial. Prev Med 199827713-9 - Mannel RS et al. Impact on individual physicians
on enrollment of patients into clinical trials.
Am J Clin Onco200326171-3
5Barriers to Enrollment in Clinical Trials
- Type of insurance coverage
- Age
- Race
- Sex
- Socioeconomic status
- Educational level
- Type of cancer
- Patient understanding of protocol
- Physicians explanation of protocol
6Legislative 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
7Objectives
- 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
8Methods
- 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
9Results
- 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
10Results - Demographics
- Mean age 60.0 yrs
- Mean age at dx 55.9 yrs
- English speaking 97.3
Education
Race
11Results continued
99.3 of respondents underwent surgery Chemot
herapy was discussed with 89.6 of respondents
12Results continued
Of the women offered a clinical trial, 53
accepted enrollment
13Factors That Influence Enrollment
- 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
14Conclusions
- 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.
15Patient Quotes
- I have always asked if there was a trial I
would benefit. The answer was noI feel it is the
responsibility of the oncologist to determine and
let you know whats 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
onlineit seems the prospect of clinical trials
is the responsibility of the patient
16Patient Quotes
- It is my hope that clinical studies will begin
to include older people people in their 80s
and beyond. We would like to have the option of
living longer too, if given the chance - In spite of a postersaying to ask about
clinical trials, I always felt that there was a
pervasive strong underlying reluctance to explore
the possibility
17Are we doing the right thing?
18Differences
19Differences Between Accept/decline Groups
20Differences between groups