Intervention for Fatigue in HCT Recipients

Not Applicable

Recruiting

• Conditions: Hematologic Cancer; Hematologic Malignancy
• Interventions: Behavioral: Usual Care; Behavioral: CBT for Fatigue

• Registration Number: NCT05715047
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-06
• Study Start: 2023-11-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-04-30
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined: * Baseline questionnaires. * Receive material from the Blood and Marrow Transplant Information Network describing common medical causes of fatigue after HCT and recommendations for management. * Questionnaires and surveys 3 and 5 months after enrollment.
CBT for Fatigue Program	CBT for Fatigue	Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined: * Baseline questionnaires. * 10 intervention sessions. * Questionnaires and surveys 3 and 5 months after enrollment.

Primary Outcome Measures

Name	Time	Method
Rate of Satisfaction (Open Pilot only)	3 month follow-up	Acceptability is defined by at least 80% of participants reporting satisfaction on the Client Satisfaction Questionnaire (range 8-32, with higher scores representing higher satisfaction).
Rate of Retention	Baseline (pre-randomization) up to 5 month follow-up	The intervention will be deemed feasible if at least 70% of participants are retained in both arms of the randomized trial.
Rate of Intervention Completion	Baseline (pre-randomization) up to 3 month follow-up	The intervention will be deemed feasible if at least 70% of participants enrolled complete at least 70% of intervention sessions of the randomized trial.
Rate of Enrollment	At recruitment	The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial.

Secondary Outcome Measures

Name	Time	Method
Improvement of Fatigue	Baseline (pre-randomization) up to 5 month follow-up	Fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F). Longitudinal differences in fatigue will be investigated between study groups (FACIT-F score range 0-52, with lower scores indicating greater fatigue).
Improvement of Mood	Baseline (pre-randomization) up to 5 month follow-up	Improvement in anxiety and depression symptoms will be assessed with the PROMIS Anxiety and Depression Scales. Longitudinal differences in anxiety and depression symptoms will be assessed between study groups (PROMIS anxiety and depression scale scores range 8-40, with higher scores indicating worse anxiety and depression symptoms).
Improvement of Quality of Life	Baseline (pre-randomization) up to 5 month follow-up	Quality of life will be assessed with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT). Longitudinal differences in quality of life will be assessed between study groups (FACT-BMT score range 0-164, with higher scores indicating better quality of life).

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States