NCT05715047

Intervention for Fatigue in HCT Recipients

Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hematologic Cancer
• Hematologic Malignancy

Interventions

Type	Name	Description
BEHAVIORAL	CBT for Fatigue	10, individualized counseling sessions with a behavioral health counselor via Zoom platform.
BEHAVIORAL	Usual Care	Standard transplant care.

Timeline

• Start date: 2023-11-29
• Primary completion: 2026-04-30
• Completion: 2026-09-01
• First posted: 2023-02-06
• Last updated: 2024-12-11

Locations

1 site across 1 country: United States