Intervention for Fatigue in HCT Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation

Conditions
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Hematologic Cancer, Hematologic Malignancy

Intervention / Treatment
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* Behavioral: CBT for Fatigue
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria adult patients (≥ 18 years) have the ability to speak and read English have undergone autologous or allogeneic transplant > 6 months prior to enrollment no evidence of disease relapse requiring therapy report moderate to severe fatigue in the past week (FSI average severity item rating ≥ 4 of 0-10) are currently receiving their care at the MGH Blood and Marrow Transplant Clinic Exclusion Criteria Patients with active cognitive impairment or uncontrolled psychiatric illness such as schizophrenia that the treating clinician believes prohibits informed consent or participation in the intervention Patients already receiving CBT care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for Fatigue Program<br>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. | Behavioral: CBT for Fatigue<br>* 10, individualized counseling sessions with a behavioral health counselor via Zoom platform.<br>|
| Active Comparator: Usual Care<br>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. | Behavioral: Usual Care<br>* Standard transplant care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Satisfaction (Open Pilot only) | 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). | 3 month follow-up | 
| Rate of Enrollment | The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial. | At recruitment | 
| Rate of Retention | The intervention will be deemed feasible if at least 70% of participants are retained in both arms of the randomized trial. | Baseline (pre-randomization) up to 5 month follow-up | 
| Rate of Intervention Completion | The intervention will be deemed feasible if at least 70% of participants enrolled complete at least 70% of intervention sessions of the randomized trial. | Baseline (pre-randomization) up to 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Fatigue | 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). | Baseline (pre-randomization) up to 5 month follow-up | 
| Improvement of Quality of Life | 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). | Baseline (pre-randomization) up to 5 month follow-up | 
| Improvement of Mood | iImprovement in anxiety and depression symptoms will be assessed with the Hospital Anxiety and Depression Scale (HADS). Longitudinal differences in anxiety and depression symptoms will be assessed between study groups (HADS anxiety and depression subscale score ranges 0-21, with higher scores indicating worse anxiety and depression symptoms). | Baseline (pre-randomization) up to 5 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematologic Cancer, Hematologic Malignancy, Hematopoietic Stem, HCT, Cognitive Behavioral Therapy, CBT