Intervention for Fatigue in HCT Recipients

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).

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.

Hematologic Cancer, Hematologic Malignancy, Hematopoietic Stem, HCT, Cognitive Behavioral Therapy, CBT

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.

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.

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).

The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial.

The intervention will be deemed feasible if at least 70% of participants are retained in both arms of the randomized trial.

The intervention will be deemed feasible if at least 70% of participants enrolled complete at least 70% of intervention sessions of the randomized trial.

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).

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).

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).

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

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