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

Contemporary Clinical Trials Communications

Mark B. Juckett¹  Natalie S. Callander²  Meredith E. Rumble³  Paul J. Rathouz⁴  Erin S. Costanzo⁵  Lisa Cadmus-Bertram⁶  Andrew Kirvin-Quamme⁶  Peiman Hematti⁷  Gwynneth Schell⁸ 

[1] Center for Sleep Medicine &Department of Kinesiology, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States;Paul P. Carbone Cancer Center, Madison, WI, United States;Research, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States;Department of Population Heath, Dell Medical School, University of Texas at Austin, Austin, TX, United States;Department of Psychiatry, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States;Division of Hematology, Oncology, Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN, United States;Paul P. Carbone Cancer Center, Madison, WI, United States;

关键词: Hematopoietic cell transplantation (HCT);    Fatigue;    Insomnia;    Depression;    Lymphoma;    Leukemia;   

DOI  :  

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown