Improving Accrual of Older Persons to Cancer Treatment Trials: A Randomized Trial Comparing an Educational Intervention With Standard Information: CALGB 360001 Gretchen G. Kimmick, Bercedis L. Peterson, Alice B. Kornblith, Jeanne Mandelblatt, Jeffrey L. Johnson, Judith Wheeler, Robin Heinze, Harvey J. Cohen, and Hyman B. Muss A B S T R A C T Purpose To design and test a geriatric educational intervention to improve accrual of cancer patients age 65 years and older to cooperative group–sponsored treatment trials. Methods Main member institutions of the Cancer and Leukemia Group B (CALGB) and its affiliates were randomly assigned to receive standard information (n = 73) or educational intervention (n = 53). Standard information included CALGB Web site access and periodic notification about existing trials. The geriatric educational intervention included standard information plus: (1) an educational seminar; (2) educational materials; (3) a list of available protocols for use on charts; (4) a monthly e-mail and mail reminders for 1 year; and (5) a case discussion seminar. The main outcome was percentage of accrual of older persons to phase II and III treatment protocols after study initiation compared with baseline. Results There were 3,032 patients entered onto trials in the baseline year, and 2,160 and 1,239 during the 2 years postintervention, respectively. Overall percentage of accrual of older patients was 37% at baseline, and 33% and 31% during the first and second years after intervention. There was no improvement in accrual in the intervention versus control arm: 36% v 32% in the first year and 31% v 31% in the second year. Conclusion Accrual of older patients was not increased by this intervention. Reasons for lack of effect include low intervention intensity, high baseline accrual rates, and closure of several high-accruing protocols during the study. More intense and multifaceted approaches will be needed to change physician (and patient) behavior and to increase accrual of older persons to clinical trials. J Clin Oncol 23:2201-2207. © 2005 by American Society of Clinical Oncology INTRODUCTION Persons age 65 or older (hereinafter referred to as “older”) comprise approximately 14% of the US population, but account for 63% of the cases of cancer in this country. 1-3 Moreover, the projected “graying of Amer- ica,” coupled with advances in cancer screening and treatment, will result in a large increase in the absolute number of older cancer patients over the coming de- cades. Thus, there is a demographic imper- ative driving the need to improve cancer care to older populations. Clinical trials are credited for a large proportion of the improvements in cancer therapy. The group at highest risk for can- cer, older patients, however, is least likely to From Cancer and Leukemia Group B (CALGB) Elderly Committee, Chicago, IL; CALGB Statistical Center; Duke University Medical Center, Durham, NC; Wake Forest University School of Medicine, Winston-Salem, NC; Dana- Farber Cancer Institute, Boston, MA, Georgetown University Medical Center, Washington, DC; and Vermont Cancer Center, Burlington, VT. Submitted September 15, 2004; accepted November 30, 2004. Supported in part by grants from the National Cancer Institute (CA31946) and supplemental funding from the National Institute on Aging. Presented in abstract form in the Proceedings of the American Society of Clinical Oncology, 2004 (abstr 8040); and in poster form at the American Society of Clinical Oncology meeting, June 8, 2004. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute. Authors’ disclosures of potential con- flicts of interest are found at the end of this article. Address reprint requests to Gretchen Kimmick, MD, MS, Duke University Medical Center, Suite 3800 Duke S, Box 3204, Durham, NC 27710; e-mail: gretchen.kimmick@duke.edu. © 2005 by American Society of Clinical Oncology 0732-183X/05/2310-2201/$20.00 DOI: 10.1200/JCO.2005.01.222 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T VOLUME 23  NUMBER 10  APRIL 1 2005 2201 Downloaded from ascopubs.org by 35.172.229.251 on June 6, 2022 from 035.172.229.251 Copyright © 2022 American Society of Clinical Oncology. All rights reserved.