Actively Recruiting
Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
Led by Massachusetts General Hospital · Updated on 2025-10-15
800
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a psychological support program called BMT-CARE can improve the quality of life and reduce stress for caregivers and patients undergoing hematopoietic cell transplant (HCT) compared to the usual care. This randomized clinical trial aims to identify what helps or hinders the use of BMT-CARE and how it affects the caregiving experience. The study is supported by the National Institutes of Health and plans to include about 400 caregivers and 400 patients. Caregivers participating in the study will be randomly assigned to either receive BMT-CARE along with usual care or to receive usual care alone. The BMT-CARE intervention is a therapist-led program consisting of six sessions that combine education about transplant care with cognitive behavioral therapy strategies aimed at improving caregiver skills and knowledge. Usual care involves meeting a transplant social worker before the transplant and additional visits as needed. The intervention lasts up to 60 days after the transplant. Participants will complete questionnaires at the start of the study and at 60, 90, and 180 days following the transplant to assess caregiver quality of life and psychosocial wellbeing. Researchers will measure outcomes using several tools including the Caregiver Oncology Quality of Life questionnaire and scales for depression, anxiety, coping, and self-efficacy. The total participation lasts up to 180 days post-transplant, during which the study team monitors the impact of the intervention on caregivers and patients.
CONDITIONS
Brief Title
BMT-CARE: Psychosocial Intervention for Transplant Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult caregivers (18 years or older) who are relatives or friends living with or having in-person contact with the patient at least twice a week
- Caregivers of patients receiving allogeneic or autologous hematopoietic cell transplant for cancer treatment
- Ability to read and respond to survey questions in English, Spanish, or with minimal interpreter help
- Adult patients (18 years or older) with hematologic malignancy planned for autologous or allogeneic transplant
- Ability to respond to questions in English, Spanish, or with minimal interpreter help
You will not qualify if you...
- Caregivers of patients undergoing transplant for benign hematologic conditions or outpatient transplant
- Caregivers with major untreated psychiatric or cognitive conditions interfering with informed consent
- Caregivers of patients who have had a transplant within the past 5 years
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment up to 60 days post-transplant
Participants randomized to the BMT-CARE group receive a therapist-delivered psychosocial intervention consisting of 6 sessions integrating education and cognitive behavioral therapy strategies to support caregivers. Those in usual care meet a transplant social worker prior to transplant and as needed.
6 intervention sessions for BMT-CARE group; social worker meetings as needed for usual care group
Duration - Up to 180 days post-transplant
Participants complete questionnaires to assess quality of life and psychosocial outcomes at multiple time points after transplant.
Questionnaires at baseline and days 60, 90, and 180 post-transplant
Trial Site Locations
Total: 3 locations
1
University of Alabama at Brimingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Areej El-Jawahri, MD
J
Jamie Jacobs, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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