Intervention for Fatigue in HCT Recipients

Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation

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).

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy; Hematologic Cancer
• Intervention / Treatment: Behavioral: CBT for Fatigue; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Nelson, PhD; Phone Number: 617-643-8574; Email: anelson11@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Ashley Nelson, PhD; Phone Number: 617-643-8574; Email: anelson11@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT for Fatigue Program; 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.	Behavioral: CBT for Fatigue; 10, individualized counseling sessions with a behavioral health counselor via Zoom platform.
Active Comparator: Usual Care; 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.	Behavioral: Usual Care; Standard transplant care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of Enrollment	The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial.	At recruitment
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Improvement of Mood	Improvement in anxiety and depression symptoms will be assessed with the PROMIS Anxiety and Depression Scales. Longitudinal differences in anxiety and depression symptoms will be assessed between study groups (PROMIS anxiety and depression scale scores range 8-40, with higher scores indicating worse anxiety and depression symptoms).	Baseline (pre-randomization) up to 5 month follow-up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Ashley Nelson, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: CBT; Cognitive Behavioral Therapy; HCT; Hematologic Malignancy; Hematologic Cancer; Hematopoietic Stem
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 22-513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No