Intervention for Fatigue in HCT Recipients

Status Recruiting

Clinical Trial Summary

The purpose of this study is to assess whether a cognitive-behavioral therapy (CBT) for fatigue intervention is acceptable, feasible, and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant (HCT).

Clinical Trial Description

This research is being done to determine whether a cognitive-behavioral therapy (CBT) for fatigue intervention is feasible and effective at managing fatigue and improving quality of life in patients following hematopoietic stem cell transplant. An open pilot of 6 participants will precede the randomized controlled trial. Study procedures for the open pilot include screening for eligibility, intervention Zoom sessions, questionnaires, and exit interviews with study staff. Patients participating in the subsequent randomized controlled trial will be randomized into one of two study groups: CBT for fatigue intervention versus usual care.Study procedures include screening for eligibility, intervention Zoom sessions (intervention arm) or receipt of informational materials about fatigue (usual care arm), and completion of study questionnaires (after consent but before randomization and at approximately 3 and 5 months post-randomization). This research study is expected to last about 3 years. It is expected about 66 people will take part in this research study. The National Heart, Lung, and Blood Institute of the National Institute of Health is providing funding for this project. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05715047
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Ashley Nelson, PhD
Phone	617-643-8574
Email	anelson11@mgh.harvard.edu
Status	Recruiting
Phase	N/A
Start date	November 28, 2023
Completion date	September 1, 2026

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