A biobehavioral intervention to enhance recovery following hematopoietic cell transplantation: Protocol for a feasibility and acceptability randomized control trial

Andrew Kirvin-Quamme, Meredith E. Rumble, Lisa Cadmus-Bertram, Mark B. Juckett, Paul J. Rathouz, Gwynneth Schell, Natalie S. Callander, Peiman Hematti, Erin S. Costanzo

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: Insomnia, fatigue, and depression are among the most persistent and distressing concerns for hematologic cancer patients recovering from hematopoietic cell transplantation (HCT). This study will evaluate a novel behavioral intervention, Restoring Sleep and Energy after Transplant (ReSET), designed to alleviate insomnia, fatigue, and depression by improving rest-activity patterns. Evidence-based behavioral strategies to improve nighttime sleep and increase non-sedentary daytime activity will be combined to optimize 24-h rest-activity patterns. Methods: The protocol herein evaluates the feasibility and acceptability of ReSET by conducting a pilot randomized controlled trial to compare the intervention with usual care. Adults undergoing HCT will be randomly assigned to ReSET or usual care. The ReSET arm will receive 3 face-to-face sessions and telephone coaching delivered in an individual format tailored to each patient. Patient-reported insomnia, fatigue, and depression will be the primary outcome measures. Actigraphy will be used to objectively quantify rest-activity patterns. Semi-structured interviews will evaluate participant satisfaction with ReSET. The goals are to determine: (1) participant satisfaction with and acceptability of the behavioral techniques; (2) facilitator fidelity and participant uptake of key intervention components; (3) ability to recruit, retain, and collect complete data from participants; (4) participant willingness to be randomized and acceptability of the control condition; and (5) validity and acceptability of the assessment strategy. Conclusion: The overarching goal is to optimize recovery following HCT with a brief, non-invasive intervention that can be implemented as a part of routine clinical care.

Original languageEnglish (US)
Article number100938
JournalContemporary Clinical Trials Communications
Volume28
DOIs
StatePublished - Aug 2022

Bibliographical note

Funding Information:
This work was supported by the National Institutes of Health (NIH) National Cancer Institute [grant number K07 CA136966 ], University of Wisconsin Carbone Cancer Center Support Grant [grant number P30 CA014520 ], and the Clinical and Translational Science Award program through the NIH National Center for Advancing Translational Sciences [grant number UL1 TR002372 ]. These funding sources were not involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.

Publisher Copyright:
© 2022

Keywords

  • Depression
  • Fatigue
  • Hematopoietic cell transplantation (HCT)
  • Insomnia
  • Leukemia
  • Lymphoma
  • Multiple myeloma

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