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)

Abstract

After completing this course, the reader will be able to:1. Cite reasons given by patients older than 65 years for their decisions to participate or not to participate in clinical trials. 2. Cite reasons given by physicians for their decisions not to enroll patients older than 65 years in clinical trials or discuss enrollment with these patients.This article is available for continuing medical education credit at CME.TheOncologist.com. CME CME 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. ABSTRACTConclusion. 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.

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

“…No trial was available for nearly half of the patients (46%). 13 Together, these and earlier studies consistently show that once a patient has access to cancer care, the absence of an available clinical trial precludes participation for about half of all patients. 14,21,22 …”

“…This model has been the basis for multiple studies examining barriers to clinical trial participation. 13,14,15 The model supposes that after cancer diagnosis and a clinic visit, an assessment of trial availability is made to identify whether a trial exists at the institution for the patient’s histology and stage. If a trial is available, an evaluation of trial eligibility is made, and if eligible, a trial is discussed with the patient.…”

“…13,14,20,21,22,27 The dominant reason for ineligibility exclusions is likely exclusions due to comorbid conditions. One recent paper comprehensively catalogued the trial eligibility criteria for a set of 21 trials in diverse cancer settings.…”

“…31,32,33 The prospective study by Javid and colleagues found that the nature of the study regimen was cited as a reason for not discussing a trial with eligible patients by 56% of physicians. 13 Physicians are also frequently concerned that clinical trial participation can interfere with the physician-patient relationship. 31,34,35 Randomization onto a phase III trial in particular subjects the treatment choice to uncertainty, and physicians may anticipate that the introduction of uncertainty will subvert patient confidence in the physician’s expertise, even if, as indicated by the existence of a randomized clinical trial, multiple treatments of potentially similar efficacy are available.…”

“…50 Some evidence suggests that attitudinal barriers on the part of physicians play a role. 13,54,55,56 In addition, older patients are likely to have higher comorbid burdens, inducing clinical exclusions. 57,58 To the extent that trials seek to reflect the population of patients for whom new trial-proven treatments will be administered, better representation of older patients on trials is critical.…”