Intervention for Fatigue in HCT Recipients

NCT05715047 | Recruiting

• 1 other identifier: 22-513
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Hematologic Cancer; Hematologic Malignancy

Keywords

Hematologic Cancer; Hematologic Malignancy; Hematopoietic Stem; HCT; Cognitive Behavioral Therapy; CBT

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Improvement of Fatigue

  Baseline (pre-randomization) up to 5 month follow-up

• Improvement of Quality of Life

  Baseline (pre-randomization) up to 5 month follow-up

• Improvement of Mood

  Baseline (pre-randomization) up to 5 month follow-up

Study Arms (2)

CBT for Fatigue Program

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

CBT for Fatigue BEHAVIORAL

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

CBT for Fatigue Program

Usual Care BEHAVIORAL

Standard transplant care.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ashley Nelson, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Nelson, PhD

CONTACT

617-643-8574; anelson11@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: November 29, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)