BMT-CARE: Psychosocial Intervention for Transplant Caregivers
Purpose
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.
Conditions
- Bone Marrow Transplant Complications
- Hematologic Malignancy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult caregivers (≥18 years) who is a relative or friend whom the patient identified as living with them or having in-person contact with them at least twice a week. - 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. Caregiver
Exclusion Criteria
- Caregivers of patients undergoing HCT for a benign hematologic condition or undergoing outpatient HCT. - Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent. Patient Inclusion Criteria: - 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator 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. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.