BMT-CARE: Psychosocial Intervention for Transplant Caregivers

Mass General Brigham

Status: Enrolling

Conditions: Hematologic Malignancy; Bone Marrow Transplant Complications

Treatments: Behavioral: BMT-CARE; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06472089

24-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Caregiver Inclusion Criteria:

• Adult caregivers (≥18 years) relative or friend of a 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.
• Caregivers of patients who have already undergone HCT within the past 5 years

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

BMT-CARE

Experimental group

Description:

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.

Treatment:

Behavioral: BMT-CARE

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care