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Is it feasible to conduct a randomised controlled trial of pretransplant exercise (prehabilitation) for patients with multiple myeloma awaiting autologous haematopoietic stem cell transplantation? Protocol for the PREeMPT study
  1. Carol Keen1,
  2. Julie Skilbeck2,
  3. Helen Ross1,
  4. Lauren Smith1,
  5. Karen Collins2,
  6. Joanne Dixey1,
  7. Stephen Walters3,
  8. Diana M Greenfield1,3,
  9. John A Snowden1,3,
  10. Susan Mawson3
  1. 1 Acute Therapy Services, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  2. 2 Department of Nursing, Sheffield Hallam University, Sheffield, UK
  3. 3 ScHARR, University of Sheffield, Sheffield, UK
  1. Correspondence to Carol Keen; carol.keen{at}sth.nhs.uk

Abstract

Introduction While myeloma is an incurable malignancy, developments in disease management have led to increased life expectancy in recent years. Treatment typically involves stem-cell transplantation. Increased survival rates equate to more patients living with the burden of both the disease and its treatment for increasing number of years, rendering myeloma a long-term condition.

Evidence exists to demonstrate the benefits of exercise for patients recovering from stem-cell transplantation, and prehabilitation—exercise before treatment—has been shown to be effective in other disease areas. To date there has been no research into prehabilitation in patients with myeloma awaiting transplantation treatment.

Our objective is to determine whether it is feasible to conduct a randomised controlled trial into pretransplant exercise for patients with multiple myeloma who are awaiting autologous stem-cell transplantation.

Methods and analysis This mixed methods study identifies patients with diagnosis of multiple myeloma who have been assigned to the autologous transplantation list and invites them to participate in six weekly sessions of individualised, supervised exercise while awaiting transplantation.

Quantitative data to determine feasibility targets include rates of recruitment, adherence and adverse events, and outcome measures including 6 min walking distance test and quality of life.

Qualitative interviews are undertaken with a purposive sample of patients to capture their experiences of the study and the intervention.

Ethics and dissemination Ethics committee approval has been obtained. Dissemination will be through open-access publications and presentations and will seek to reach multiprofessional bases as well as patients and carer groups, addressing the widespread interest in this area of research.

Trial registration number NCT03135925; Pre-results.

  • myeloma
  • bone marrow transplantation
  • rehabilitation medicine

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors JD conceived of the idea and secured funding with CK, JAS, KC, DMG, SW and SM, who is the chief investigator. Ethics and research governance applications were made by SM, CK and HR. JS, HR and LS provided intellectual input and study design for the final protocol of the study. All authors were involved in drafting or critically revising this work, and in final approval of the version to be published.

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests SW reports personal fees from Book Royalties, grants from NIHR and MRC, personal fees from external examining.

  • Patient consent Not required.

  • Ethics approval NHS Health Research Authority - Yorkshire and Humber 16/YH/0304.

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