Intervention for Fatigue in HCT Recipients

Mass General Brigham

Status: Enrolling

Conditions: Hematologic Malignancy; Hematologic Cancer

Treatments: Behavioral: Usual Care; Behavioral: CBT for Fatigue

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05715047

22-513

Details and patient eligibility

About

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).

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• no new other malignancy requiring therapy after transplant
• 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
• Patients living with untreated sleep apnea
• Patients with hypoxemia requiring oxygen supplementation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

CBT for Fatigue Program

Experimental group

Description:

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.

Treatment:

Behavioral: CBT for Fatigue

Usual Care

Active Comparator group

Description:

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 adapted material from the MGH Bone Marrow Transplant Survivorship program outlining common contributors to fatigue after transplant and recommendations for management. * Questionnaires and surveys 3 and 5 months after enrollment.

Treatment:

Behavioral: Usual Care