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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 Yes 129 (89.6%) No 13 (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 cappuccini.ppt Presentation Transcript

  • “ 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 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.
  • 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 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 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 1998;27:713-9
    • 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
  • 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
  • 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
  • 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
  • Results - Demographics
    • Mean age 60.0 yrs
    • Mean age at dx 55.9 yrs
    • English speaking 97.3
    Race Education
  • Results continued 99.3% of respondents underwent surgery Chemotherapy was discussed with 89.6% of respondents
  • Results continued Of the women offered a clinical trial, 53% accepted enrollment
  • 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
  • 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.
  • 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”
  • 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?
  • Differences 59% 65% Education (high school or some college) 41.4% 58.3% City of Diagnosis (Portland Metro) 56 55.1 Mean age Not offered Offered
  • Differences Between Accept/decline Groups 64.6% 53% Education (High school or some college) 53.3% 63.2% City of Dx (Portland Metro) 55.9 56.9 Mean age Decline Accept
  • Differences between groups