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A population-based study of invitation to and participation in clinical trials among women with early-stage breast cancer

  • Epidemiology
  • Published:
Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

Purpose

Although many studies clearly demonstrate disparities in cancer clinical trial enrollment, there is a lack of consensus on potential causes. Furthermore, virtually nothing is known about associations between patients’ decision-making style and their participation in clinical trials.

Methods

Women with newly diagnosed, stage 0–II breast cancer reported to the Georgia and Los Angeles County Surveillance, Epidemiology, and End Results (SEER) registries in 2013–2014 were surveyed approximately seven months after diagnosis. We investigated two primary outcome variables: (1) invitation to participate in a clinical trial, (2) participation in a clinical trial. We evaluated bivariate associations using Chi-squared tests and used multivariable logistic regression models to investigate associations between patient variables, including decision-making style, and the primary outcomes.

Results

2578 patients responded (71% response rate); 30% were > age 65, 18% were black, 18% were Latina, 29% had ≤ high school education. 10% of patients reported invitation to participate in a clinical trial; 5% reported participation in a clinical trial. After adjustment younger age, receipt of chemotherapy or radiation, disease stage, and a more rational (versus more intuitive) decision-making style were associated with a higher odds of invitation to participate. Being married was associated with a higher odds of participation; having an annual family income ≥ $40,000 was associated with a lower odds of participation.

Conclusions

10% of patients reported invitation to participate in a clinical trial, and half of these reported participation. Invitation to participate varied by age and decision-making style, and participation varied by marital status and income.

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Acknowledgements

This study was funded by Grant P01 CA163233 to the University of Michigan from the National Cancer Institute (NCI). The collection of Los Angeles County cancer incidence data used in this study was supported by the California Department of Public Health pursuant to California Health and Safety Code Section 103885; the Centers for Disease Control and Prevention's National Program of Cancer Registries under cooperative agreement 5NU58DP003862‐04/DP003862; and the NCI's Surveillance, Epidemiology, and End Results program under contract HHSN261201000140C awarded to the Cancer Prevention Institute of California, contract HHSN261201000035C awarded to the University of Southern California, and contract HHSN261201000034C awarded to the Public Health Institute. Cancer incidence data collection in Georgia was supported by contract HHSN261201300015I, Task Order HHSN26100006 from the NCI, and cooperative agreement 5NU58DP003875‐04‐00 from the Centers for Disease Control and Prevention. Monica A. Patel was supported by the National Cancer Institute (through Grant T32CA009357). Christine M. Veenstra was supported by the National Cancer Institute (through grant K07CA19675201). The ideas and opinions expressed herein are those of the authors. The State of California, the Department of Public Health, the National Cancer Institute, and the Centers for Disease Control and Prevention and their contractors and subcontractors had no role in the design or conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript.

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Authors and Affiliations

  1. Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, USA

    Monica A. Patel & Christine M. Veenstra

  2. Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA

    Jennifer L. Shah & Reshma Jagsi

  3. Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA

    Paul H. Abrahamse

  4. Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA

    Jennifer L. Shah & Reshma Jagsi

  5. Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA

    Steven J. Katz & Sarah T. Hawley

  6. Department of Health Management and Policy, University of Michigan, Ann Arbor, MI, USA

    Steven J. Katz

  7. US Department of Veterans Affairs Health Services Research and Development, University of Michigan, Ann Arbor, MI, USA

    Sarah T. Hawley

  8. Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA

    Jennifer L. Shah, Reshma Jagsi, Steven J. Katz, Sarah T. Hawley & Christine M. Veenstra

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  1. Monica A. Patel
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  2. Jennifer L. Shah
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Corresponding author

Correspondence to Christine M. Veenstra.

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Conflicts of interest

Dr. Patel declares that she has no conflict of interest. Dr. Shah declares that she has no conflict of interest. Mr. Abrahamse declares that he has no conflict of interest. Dr. Jagsi declares receiving grants from the National Institutes of Health and National Cancer Institute, Doris Duke Foundation, and Komen Foundation; receiving grants and personal fees from the Greenwall Foundation; personal fees from Vizient and Amgen; owning stock in Equity Quotient. Dr. Katz declares that he has no conflict of interest. Dr. Hawley declares that she has no conflict of interest. Dr. Veenstra declares that she has no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Patel, M.A., Shah, J.L., Abrahamse, P.H. et al. A population-based study of invitation to and participation in clinical trials among women with early-stage breast cancer. Breast Cancer Res Treat 184, 507–518 (2020). https://doi.org/10.1007/s10549-020-05844-7

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  • DOI: https://doi.org/10.1007/s10549-020-05844-7

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