A Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Cell Transplantation: Protocol for a Feasibility and Acceptability Randomized Control Trial

Overview

Journal Contemp Clin Trials Commun

Date 2022 Jun 6

PMID 35664502

Authors

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

Affiliations

Soon will be listed here.

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, (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.

Citing Articles

Biobehavioral mechanisms underlying symptoms in cancer patients with chronic graft-versus-host disease.

Hansen J, Rumble M, Coe C, Juckett M, Foster M, Dickson D Brain Behav Immun. 2024; 123:185-192.

PMID: 39288894 PMC: 11624090. DOI: 10.1016/j.bbi.2024.09.017.

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