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Completed

NCT Number: NCT05715047

Intervention for Fatigue in HCT Recipients

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).

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Key information

Conditions

Hematologic Cancer Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT for Fatigue

Behavioral

10, individualized counseling sessions with a behavioral health counselor via Zoom platform.

Usual Care

Behavioral

Standard transplant care.

Primary outcomes

  1. Rate of Satisfaction (Open Pilot only)

    Time frame: 3 month follow-up

    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).

  2. Rate of Enrollment

    Time frame: At recruitment

    The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial.

  3. Rate of Retention

    Time frame: Baseline (pre-randomization) up to 5 month follow-up

    The intervention will be deemed feasible if at least 70% of participants are retained in both arms of the randomized trial.

  4. Rate of Intervention Completion

    Time frame: Baseline (pre-randomization) up to 3 month follow-up

    The intervention will be deemed feasible if at least 70% of participants enrolled complete at least 70% of intervention sessions of the randomized trial.

Secondary outcomes

  1. Improvement of Fatigue

    Time frame: Baseline (pre-randomization) up to 5 month follow-up

    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).

  2. Improvement of Quality of Life

    Time frame: Baseline (pre-randomization) up to 5 month follow-up

    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).

  3. Improvement of Mood

    Time frame: Baseline (pre-randomization) up to 5 month follow-up

    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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2023
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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