Clinical trial NCT05715047: Intervention for Fatigue in HCT Recipients
Official title: Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Cancer
Hematologic Malignancy
Keywords: Hematologic Cancer
Hematologic Malignancy
Hematopoietic Stem
HCT
Cognitive Behavioral Therapy
CBT
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-02-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Rate of Satisfaction (Open Pilot only)
timeFrame: 3 month follow-up
measure: Rate of Enrollment
timeFrame: At recruitment
measure: Rate of Retention
timeFrame: Baseline (pre-randomization) up to 5 month follow-up
measure: Rate of Intervention Completion
timeFrame: Baseline (pre-randomization) up to 3 month follow-up
Secondary outcomes:
measure: Improvement of Fatigue
timeFrame: Baseline (pre-randomization) up to 5 month follow-up
measure: Improvement of Quality of Life
timeFrame: Baseline (pre-randomization) up to 5 month follow-up
measure: Improvement of Mood
timeFrame: Baseline (pre-randomization) up to 5 month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ashley Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: