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Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors
  1. Courtney J Stevens1,2,
  2. Mark T Hegel2,
  3. Marie Anne Bakitas3,
  4. Martha Bruce1,2,
  5. Andres Azuero3,
  6. Maria Pisu4,
  7. Mary Chamberlin2,5,
  8. Kimberly Keene6,
  9. Gabrielle Rocque7,
  10. Daphne Ellis1,
  11. Tiffany Gilbert1,
  12. Jamme L Morency8,
  13. Robin M Newman9,
  14. Megan E Codini8,
  15. Karen E Thorp8,
  16. Sarah M dos Anjos10,
  17. Danielle Z Cloyd3,
  18. Jennifer Echols3,
  19. Ashley N Milford3,
  20. Stacey A Ingram11,
  21. Jasmine Davis11,
  22. Kathleen Doyle Lyons1,2
  1. 1 Psychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
  2. 2 Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA
  3. 3 School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA
  4. 4 Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA
  5. 5 Department of Hematology Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
  6. 6 Radiation Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  7. 7 Medicine, Divisions of Hematology and Oncology, and Geriatrics, Gerontology, and Palliative Care, University of Alabama at Birmingham, Birmingham, Alabama, USA
  8. 8 Physical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
  9. 9 Occupational Therapy, Boston University College of Health and Rehabilitation Sciences Sargent College, Boston, Massachusetts, USA
  10. 10 Occupational Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA
  11. 11 Department of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  1. Correspondence to Dr Kathleen Doyle Lyons; kathleen.d.lyons{at}dartmouth.edu

Abstract

Introduction Many breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors’ optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors.

Methods and analysis This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors’ activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1–3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later.

Ethics and dissemination Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals.

Trial registration number NCT03915548; Pre-results.

  • adult oncology
  • breast tumours
  • rehabilitation medicine
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors KDL and MTH conceived the study and KDL, MTH, MB, MAB, AA, MP, MC and KK contributed to the study design. Acquisition of data was performed by KDL, MAB, TG, DE, ANM, JLM, RMN, KET, MEC, SMdA, DZC, JE, SAI, JD and GR. CJS and KDL drafted the manuscript and all authors provided comments and feedback for improving the manuscript. All authors approved the final version of the manuscript and are responsible for their contributions.

  • Funding Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number R01CA225792. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

  • Disclaimer The funder did not have a role in the design or conduct of the study and the authors have ultimate authority over study activities. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.

  • Competing interests GR reports grants and other from Genetech, grants and other from Pfizer, grants and other from Carevive, outside the submitted work.

  • Patient consent for publication Not required.

  • Ethics approval This protocol is approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single IRB of record for both study sites.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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