Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials

Authors

  • Alice B. Kornblith Ph.D.,

    Corresponding author
    1. Dana-Farber Cancer Institute, Boston, Massachusetts
    • Women's Cancers Program, Room D1210, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115
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    • Fax: (617) 632-1930

  • Margaret Kemeny M.D.,

    1. Queens Medical Center, Queens, New York
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  • Bercedis L. Peterson Ph.D.,

    1. Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham, North Carolina
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  • Judith Wheeler M.P.H.,

    1. Cancer and Leukemia Group B Data Management Center, Duke University Medical Center, Durham, North Carolina
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  • Jeffrey Crawford M.D.,

    1. Duke University and Veterans Administration Medical Center, Durham, North Carolina
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  • Nancy Bartlett M.D.,

    1. Washington University Medical Center, St. Louis, Missouri
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  • Gini Fleming M.D.,

    1. University of Chicago Medical Center, Chicago, Illinois
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  • Stephen Graziano M.D.,

    1. State University of New York Upstate Medical University, Syracuse, New York
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  • Hyman Muss M.D.,

    1. Vermont Cancer Center, Burlington, Vermont
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  • Harvey Jay Cohen M.D.,

    1. Duke University and Veterans Administration Medical Center, Durham, North Carolina
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  • Cancer and Leukemia Group B

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    • The following institutions participated in this study: CALGB Statistical Office, Durham, NC (Stephen George, Ph.D.; grant CA 33601); Duke University Medical Center, Durham, NC (Jeffrey Crawford, M.D.; grant CA 33601); Mount Sinai School of Medicine, New York, NY (James F. Holland, M.D.; grant CA 04457); North Shore University Hospital, Manhasset, NY (Daniel R. Budman, M.D.; grant CA 35279); Roswell Park Memorial Institute, Buffalo, NY (Ellis Levine, M.D.; grant CA 02599); SUNY Upstate Medical University, Syracuse, NY (Stephen L. Graziano, M.D.; grant CA 21060); University of Chicago Medical Center, Chicago IL (Gini Fleming, M.D.; grant CA 41287); University of Maryland Cancer Center, Baltimore, MD (David Van Echo, M.D.; grant CA 31983); University of Vermont Cancer Center, Burlington, VT (Hyman B. Muss, M.D.; grant CA 21060); Wake Forest University School of Medicine, Winston-Salem, NC (David D. Hurd, M.D.; grant CA 03927); and Washington University School of Medicine, St. Louis, MO (Nancy Bartlett, M.D.; grant CA 77440).


  • The authors are indebted to all of the physicians who took the time to participate in this survey. It also was clear that this study could not have been done without the clinical research associates and nurses at the major participating sites who juggled the complicated research procedures of the larger pilot study, including this survey. The authors' special thanks go to the following individuals: Ms. Sarah Beddingfield (Duke University Medical Center), Ms. Donna Galgano (North Shore-Long Island Jewish Medical Center), Ms. Jan Marie McEvilly (University of Chicago Medical Center), Ms. Donna Silver (Vermont Cancer Center), Ms. Laurie Smith (Washington University Medical Center), and Ms. Diane Gould (State University of New York Upstate Medical University).

Abstract

BACKGROUND

Prior research has documented the under-representation in clinical trials of older patients with cancer. In part of a larger study to test the magnitude of these barriers to entering eligible older patients with carcinoma of the breast into clinical trials (Cancer and Leukemia Group B [CALGB] trial 9670), barriers to accruing eligible older patients to clinical trials were obtained from the physician's perspective.

METHODS

One hundred fifty-six physicians (85% oncologists) who treated patients with breast carcinoma at 10 CALGB institutions completed a questionnaire concerning what they perceived as barriers to enrolling older patients with breast carcinoma on clinical trials and possible interventions that may improve accrual.

RESULTS

Physicians' perceptions of the most important barriers to accrual of older patients were: 1) elderly patients have significant comorbid conditions that are not excluded by the protocol but that may affect how they would respond to treatment (16%); elderly patients have difficulty understanding what is required in a complicated treatment trial, resulting in poor compliance (16%); treatment toxicity (14%); and elderly patients often do not meet the eligibility criteria (15%). Oncologists most frequently suggested that the most effective interventions for improving the accrual of elderly patients to trials included making personnel available in the clinic to explain clinical trials to older patients and their families (25%) and providing physicians with educational materials concerning treatment toxicity in the elderly (18%).

CONCLUSIONS

Physicians viewed barriers to accruing older patients with breast carcinoma to clinical trials as multidimensional, with the most important involving protocol requirements, treatment specific issues, and older patients' medical and cognitive characteristics. Thus, a variety of interventions would be needed to improve accrual of older patients to clinical trials, including increasing physicians' knowledge concerning treatment toxicity in the elderly, simplifying protocol requirements, and reducing treatment toxicity. Cancer 2002;95:989–96. © 2002 American Cancer Society.

DOI 10.1002/cncr.10792

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