A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316).
OBJECTIVE
Patients older than 65 years are underrepresented in clinical trials. We conducted a prospective study (SWOG S0316) to determine physician- and patient-perceived barriers to breast cancer clinical trial enrollment for older patients.


METHODS
Eight geographically diverse SWOG institutions participated. The study assessed patients' and physicians' decisions to enroll in or decline clinical treatment trials, including demographics, trial availability, and eligibility. Patient and physician questionnaires elicited concerns related to treatment, medical status, age, family, and financial or transportation concerns.


RESULTS
A total of 1,079 patients were registered and eligible and 909 (84%) returned for follow-up. The major reason for nonaccrual was either trial unavailability or ineligibility (60%). Older patients were less likely to be eligible for trials (65% for age ≥65 years vs. 78% for age <65 years). If eligible, trial participation rates did not differ significantly by age (34% for age ≥65 years vs. 40% for age <65 years). Patients ≥65 years more often were concerned about side effects, had friends opposed to participation, or believed that participation would not benefit other generations. When trials were available and patients were eligible, physicians discussed trial participation with 76% of patients <65 years versus 58% of patients ≥65 years of age. For patients ≥65 years, 11% of physicians indicated age as a reason they did not enroll a patient in a clinical trial.


CONCLUSIONS
Trial unavailability or patient ineligibility were the major reasons for lack of enrollment in breast cancer clinical trials for patients of all ages in this prospective study. Older patients were less likely to be eligible for trials, but if eligible they participated at similar rates to younger patients.
Department of Surgery, Division of Surgical Oncology, University of Washington Medical Center, 1959 NE Pacific St., Seattle, WA 98195-6410, USA. sjavid@u.washington.edu
Sara H
SH
Javid
Joseph M
JM
Unger
Julie R
JR
Gralow
Carol M
CM
Moinpour
Antoinette J
AJ
Wozniak
J Wendall
JW
Goodwin
Primo N
PN
Lara
Pamela A
PA
Williams
Laura F
LF
Hutchins
Carolyn C
CC
Gotay
Kathy S
KS
Albain
D000368:Aged; D001943:Breast Neoplasms / Q000628:therapy*; D002986:Clinical Trials as Topic; D003657:Decision Making; D004608:Eligibility Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D010358:Patient Participation; D018579:Patient Selection; D010820:Physicians; D011446:Prospective Studies; D011795:Surveys and Questionnaires