BMT-CARE: Psychosocial Intervention for Transplant Caregivers
NCT ID: NCT06472089
Last Updated: 2025-10-15
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
800 participants
INTERVENTIONAL
2025-01-10
2029-02-28
Brief Summary
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Detailed Description
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Caregivers will be randomized into one of the two study groups: BMT-CARE plus usual care, or usual care.
Participation in this study is expected to last up to 180 days after HCT.
Investigators expect that about 400 caregivers and up to 400 patients treated with HCT will take part in this research study.
The National Institutes of Health is supporting this research by providing funding.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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BMT-CARE
Participants randomized to BMT-CARE plus usual care will complete the following:
* Questionnaires at baseline, and days 60, 90 and 180 post HCT.
* Receive the BMT-CARE intervention from enrollment up to 60 days post-HCT. BMT-CARE is a -6-session caregiver-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that integrates HCT-related education with CBT strategies to enhance caregiver knowledge and skills.
* Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.
BMT-CARE
Therapist-delivered psychosocial intervention comprised of 6 sessions
Usual Care
Participants randomized to usual care will complete the following
* Questionnaires at baseline, and days 60, 90 and 180 post HCT.
* Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.
Usual Care
Meeting a transplant social worker prior to HCT and as needed for extra visits
Interventions
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BMT-CARE
Therapist-delivered psychosocial intervention comprised of 6 sessions
Usual Care
Meeting a transplant social worker prior to HCT and as needed for extra visits
Eligibility Criteria
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Inclusion Criteria
* Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer.
* Ability to read and respond to survey questions in English, Spanish or with minimal assistance from an interpreter.
* Adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic HCT.
* Ability to respond to questions in English, Spanish, or with minimal assistance from an interpreter.
Exclusion Criteria
* Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
* Caregivers of patients who have already undergone HCT within the past 5 years
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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El-Jawahri, Areej,M.D.
Associate Professor of Medicine
Principal Investigators
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Areej El-Jawahri, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Jamie Jacobs, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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University of Alabama at Brimingham
Birmingham, Alabama, United States
Moffitt Cancer Center
Tampa, Florida, United States
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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Other Identifiers
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24-013
Identifier Type: -
Identifier Source: org_study_id
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