Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-11-29
2026-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
CBT for Fatigue
10, individualized counseling sessions with a behavioral health counselor via Zoom platform.
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.
Usual Care
Standard transplant care.
Interventions
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CBT for Fatigue
10, individualized counseling sessions with a behavioral health counselor via Zoom platform.
Usual Care
Standard transplant care.
Eligibility Criteria
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Inclusion Criteria
* 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 already receiving CBT care
* Patients living with untreated sleep apnea
* Patients with hypoxemia requiring oxygen supplementation
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Ashley M. Nelson, PhD
Principal Investigator
Principal Investigators
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Ashley Nelson, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Ashley Nelson, PhD
Role: primary
Other Identifiers
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22-513
Identifier Type: -
Identifier Source: org_study_id