NCT06472089

BMT-CARE: Psychosocial Intervention for Transplant Caregivers

Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption.

Detailed description

This is a randomized clinical trial to determine whether a psychosocial intervention (BMT-CARE) is effective at improving the quality of life and reducing psychosocial distress of caregivers and patients treated with hematopoietic cell transplant (HCT). The BMT-CARE intervention was developed with the goal of improving the experience and needs of caregivers of patients treated with HCT. 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

• Bone Marrow Transplant Complications
• Hematologic Malignancy

Interventions

Type	Name	Description
BEHAVIORAL	BMT-CARE	Therapist-delivered psychosocial intervention comprised of 6 sessions
BEHAVIORAL	Usual Care	Meeting a transplant social worker prior to HCT and as needed for extra visits

Timeline

• Start date: 2025-01-10
• Primary completion: 2028-05-01
• Completion: 2029-02-01
• First posted: 2024-06-24
• Last updated: 2025-10-15

Locations

3 sites across 1 country: United States