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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05715047
Other study ID # 22-513
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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