Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Contact Information
Primary
Ashley Nelson, PhD
anelson11@mgh.harvard.edu
617-643-8574
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 66
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)