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									“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
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 potent ial 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.
                                    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

     86% of respondents felt that women should
      be asked to participate in clinical trials, with
      33% stating that they would accept

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.
                  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
 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
     Barriers to Enrollment in
           Clinical Trials
   Type of insurance coverage
   Age
   Race
   Sex
   Socioeconomic status
   Educational level
   Type of cancer
   Patient understanding of protocol
   Physician’s explanation of protocol
       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
 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
 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
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
     Results - Demographics
   Mean age 60.0 yrs
   Mean age at dx 55.9 yrs
   English speaking 97.3            High
                                     School or
                                     GED            17.6
                                     Some                     25.2
                                     Bachelors   21.1
                                     Graduate              34.7
                   American Indian


                 Race                             Education
             Results continued
                                      Type of Surgeon

99.3% of respondents
underwent surgery

                        Gyn Onc     Ob/Gyn   Gen Surgeon     Other

                                Discussion of Chemotherapy

Chemotherapy was
discussed with 89.6%   30
of respondents         20
                            Gyn Onc Med Onc Ob/Gyn   Nurse     Gen
           Results continued
Did you know about clinical               Were you offered enrollment in a trial?
                                    250                                 226


                              NO    100

                                     50            36

                                                 YES                   NO

  Of the women offered a clinical trial, 53% accepted
     Factors That Influence

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

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.
              Patient 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 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”
Are we doing the right thing?

                   Offered    Not offered
Mean age               55.1        56
City of               58.3%      41.4%
(Portland Metro)

Education             65%         59%
(high school or
some college)
  Differences Between
 Accept/decline Groups
                   Accept    Decline

Mean age              56.9      55.9

City of Dx           63.2%      53.3%
(Portland Metro)

Education             53%       64.6%
(High school or
some college)
Differences between groups

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