RecruitingInterventional

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

NCT ID: NCT06472089Sponsor: Massachusetts General HospitalLast updated: 2025-10-15

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.

Arms & interventions

BehavioralBMT-CARE
Therapist-delivered psychosocial intervention comprised of 6 sessions
BehavioralUsual Care
Meeting a transplant social worker prior to HCT and as needed for extra visits

Outcome measures

Primary

Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Compare caregiver QOL as measured by the CARGOQOL between the two study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
Time frame: Up to 60 days post-HCT

Secondary

Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Time frame: Up to 180 days post-HCT
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire
Time frame: Up to 180 days post-HCT
Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale
Time frame: Up to 180 days post-HCT
Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale
Time frame: Up to 180 days post-HCT
Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire
Time frame: Up to 180 days post HCT
Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire
Time frame: Up to 180 days post-HCT

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (3)

University of Alabama at Brimingham

Birmingham, Alabama, 35294

Recruiting

James Dionne-Odom · Contact

205-934-7597 dionneod@uab.edu

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Heather Jim · Contact

813-745-6369 heather.jim@moffitt.org

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Recruiting

Areej El-Jawahri, MD · Contact

617-643-4003 AEL-JAWAHRI@PARTNERS.ORG

Areej El-Jawahri, MD · Principal Investigator