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Barriers to enrolling patients with ovarian cancer in clinical trials in the state of Oregon

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... decade, clinical trial enrollment rates ranged from 3% for breast cancer to 14 ... for ovarian cancer, knowledge about and participation in clinical trials ... – PowerPoint PPT presentation

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Title: Barriers to enrolling patients with ovarian cancer in clinical trials in the state of Oregon


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 Womens
Health March 25, 2006
2
Enrollment 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.
3
Public 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.
4
Role 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

5
Barriers 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

6
Legislative 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
Objectives
  • 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
Methods
  • 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
Results
  • 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
Results - Demographics
  • Mean age 60.0 yrs
  • Mean age at dx 55.9 yrs
  • English speaking 97.3

Education
Race
11
Results continued
99.3 of respondents underwent surgery Chemot
herapy was discussed with 89.6 of respondents
12
Results continued
Of the women offered a clinical trial, 53
accepted enrollment
13
Factors 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

14
Conclusions
  • 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
Patient 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

16
Patient 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

17
Are we doing the right thing?
18
Differences
19
Differences Between Accept/decline Groups
20
Differences between groups
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