Lessons learned from enrollment in the BEST study—A multicenter, randomized trial of group psychosocial support in metastatic breast cancer

doi:10.1016/S0895-4356(99)00148-1

Journal of Clinical Epidemiology

Volume 53, Issue 1, January 2000, Pages 47-55

https://doi.org/10.1016/S0895-4356(99)00148-1 Get rights and content

Abstract

The BEST study, a multicenter randomized trial of group psychosocial support in metastatic breast cancer, had several unusual features that may have influenced recruitment, notably the group nature of the intervention and the need for close collaboration between medical and psychosocial investigators. The recruitment process was examined in light of these features. Establishment of study centers was facilitated by involvement of experienced medical investigators who had successfully collaborated in previous research projects. Systematic evaluation of potential subjects or direct recruitment by psychosocial investigators optimized recruitment; however, the group nature of the intervention prolonged recruitment. Overall, 652 women were approached and 237 (43.3% of those medically eligible) randomized. Using population-based estimates, 24.3% of women with metastatic breast cancer were assessed for the study and 8.7% randomized. A randomization ratio of 2:1 was required to form and maintain groups. Competing clinical trials were the greatest barrier to recruitment. Five lessons were learned during recruitment for this trial: (1) multicenter randomized trials of psychosocial interventions are feasible, even in very ill patients, (2) the use of a group intervention effectively increased the required sample size by 50%, (3) similarity of randomization rates suggests that generalizability of study results will probably be comparable to that of other randomized cancer trials, (4) multidisciplinary collaborations and involvement of experienced researchers facilitated enrollment, and (5) most challenges encountered in recruitment were similar to those seen in all clinical trials.

Introduction

Recruitment is the cornerstone of randomized clinical trials and, is many instances, the greatest challenge to successful completion of a trial. Recruitment, rather than a priori sample size calculations, often determines the final power of a trial [1]; suboptimal recruitment reduces power and increases the likelihood that important clinical effects will be missed. The recruitment process may also impact on the generalizability of study results, exerting an effect that is over and above the widely recognized impact of eligibility criteria [2]. Eligibility criteria define the subset of all patients with the illness being investigated that can potentially be included in the trial. Only a portion of this subset of patients is randomized. It is difficult, if not impossible, to characterize the subtle selection processes that determine which eligible patients are randomized and which are not; however, the extent to which selection occurs in different studies may provide a clue to the relative generalizability of results amongst studies.

In this article we examine recruitment for the Breast Expressive-Supportive Therapy (BEST) Study, a randomized trial of group psychosocial support in metastatic breast cancer [3]. This trial arose out of work by Spiegel et al. suggesting that participation in a specific type of weekly support group led to prolonged survival in women with metastatic breast cancer [4]. Because this result was unexpected, and because of imbalances in baseline prognostic factors, replication was recommended [5]. The BEST Study represents one attempt at replication. It has several features—the psychosocial nature of the intervention, the group format of the intervention, and the multidisciplinary nature of the study—that may have influenced recruitment.

Section snippets

General design of the BEST study

The BEST Study [3] is a Canadian multicenter, randomized trial comparing a specific manual-based form of group psychosocial support (expressive-supportive therapy) [6] combined with educational materials and usual psychosocial and medical care, to educational materials and usual medical and psychosocial care alone. The trial is coordinated at the Samuel Lunenfeld Research Institute at Mount Sinai Hospital, University of Toronto, which is also a study center. Other participating centers include

Recruitment

Recruitment, summarized in Table 1, began in June 1993 and ended in December 1997. A total of 652 women were assessed (Step 1). Ninety-six (14.7%) of these were ineligible on initial contact (Step 2). Of the remaining 556 women, 299 (53.6% of eligible women, 45.9% of all women) declined participation in the study (Step 3). One hundred and eighty-two (32.7% of eligible women, 28.1% of all women) of these declined after being provided with a brief description of the study. One hundred and sixteen

Discussion

We have described recruitment for a multicenter, randomized clinical trial of group psychosocial support in metastatic breast cancer. Recruitment took approximately 50% longer than expected and required the involvement of two additional centers. A population base of at least 600,000 per center was necessary for the successful formation and maintenance of groups.

We estimate that just under 25% of potentially eligible women were formally assessed for the BEST Study. This was highest in centers

Acknowledgments

This research has been funded by the Medical Research Council of Canada and the Canadian Breast Cancer Research Initiative.

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Original articlesLessons learned from enrollment in the BEST study—A multicenter, randomized trial of group psychosocial support in metastatic breast cancer

Abstract

Introduction

Section snippets

General design of the BEST study

Recruitment

Discussion

Acknowledgments

Cancer Treat Rev

Lancet

Psychosomatics

Lancet

Eur J Cancer

Eur J Cancer

Recruitment experience in clinical trialsliterature summary and annotated bibliography

Contr Clin Trials

Risk factor and behavioural correlates of willingness to participate in cancer prevention trials

Nutr Cancer

Supportive-Expressive Group TherapyA Treatment Manual of Psychosocial Intervention for Women with Recurrent Breast Cancer

The Theory and Practice of Group Psychotherapy

Adjuvant psychological therapy for patients with cancera prospective randomized trial

Br Med J

Is group psychotherapy feasible for oncology outpatients, attenders selected on the basis of psychological morbidity?

Br J Cancer

Original articles
Lessons learned from enrollment in the BEST study—A multicenter, randomized trial of group psychosocial support in metastatic breast cancer