NCT06472089NARecruiting

BMT-CARE: Psychosocial Intervention for Transplant Caregivers

Massachusetts General Hospital

Start Date

1/10/2025

Completion Date

2/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BEHAVIORAL

BMT-CARE

BEHAVIORAL

Usual Care

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Conditions

Bone Marrow Transplant ComplicationsHematologic Malignancy

Locations

University of Alabama at Brimingham

Birmingham, Alabama 35294

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts 02114

United States