Intervention for Fatigue in HCT Recipients

Hematologic Malignancy Clinical Trial

Official title:

Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715047
• Other study ID #: 22-513
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Ashley Nelson, PhD
• Phone: 617-643-8574
• Email: anelson11[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 1, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Cancer
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Behavioral:
• CBT for Fatigue
10, individualized counseling sessions with a behavioral health counselor via Zoom platform.
• Usual Care
Standard transplant care.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of Enrollment	The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial.	At recruitment
Primary	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
Primary	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	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
Secondary	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
Secondary	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