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Why Cancer Patients Enter Randomized Clinical Trials: Exploring the Factors That Influence Their Decision

From the Juravinski Cancer Centre, Hamilton Health Sciences; Department of Medicine, Supportive Care Cancer Research Unit, School of Nursing, Faculty of Health Sciences, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton; Department of Nursing, Hospital for Sick Children; Sunnybrook and Women's College Hospital; University of Toronto, Toronto, Ontario

Address reprint requests to J.R. Wright, MD, FRCP(C), Juravinski Cancer Centre, 699 Concession St, Hamilton, Ontario, L8V 5C2; e-mail: jim.wright{at}hrcc.on.ca

PURPOSE: Few interventions have been designed and tested to improve recruitment to clinical trials in oncology. The multiple factors influencing patients' decisions have made the prioritization of specific interventions challenging. The present study was undertaken to identify the independent predictors of a cancer patient's decision to enter a randomized clinical trial.

METHODS: A list of factors from the medical literature was augmented with a series of focus groups involving cancer patients, physicians, and clinical research associates (CRAs). A series of questionnaires was developed with items based on these factors and were administered concurrently to 189 cancer patients, their physicians, and CRAs following the patient's decision regarding trial entry. Forward logistic regression modeling was performed using the items significantly correlated (by univariate analysis) with the decision to enter a clinical trial.

RESULTS: A number of items were significantly correlated with the patient's decision. In the multivariate logistic regression model, the patient's perception of personal benefit was the most important, with an odds ratio (OR) of 3.08 (P < .05). CRA-related items involving supportive aspects of the decision-making process were also important. These included whether the CRA helped with the decision (OR = 1.71; P < .05), and whether the decision was hard for the patient to make (OR = 0.52; P < .05).

CONCLUSION: Strategies that better address the potential benefits of trial entry may result in improved accrual. Interventions or aids that focus on the supportive aspects of the decision-making process while respecting the need for information and patient autonomy may also lead to meaningful improvements in accrual.

Supported by a grant from the Hamilton Regional Cancer Centre Foundation.

Presented in part at the Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003, and at the Annual Meeting of the Canadian Association of Radiation Oncologists in Montreal, Quebec, Canada, October 3-5, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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