“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 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.

Public AttitudesPublic AttitudesPhone 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 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

Barriers to Enrollment in Barriers 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

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

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

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

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

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

HighSchool orGED Somecollege

BachelorsDegree

Graduateschool

96%

2%

2%

White

Asian

American Indian

Race Education

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 GenSurgeon

Discussion of Chemotherapy

99.3% of respondents underwent surgery

Chemotherapy was discussed with 89.6% of respondents

Results continuedResults continuedDid 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

Factors That Influence Factors 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

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.

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”

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”

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 offeredOffered

DifferencesDifferences

Differences Between Differences 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

Differences between groups