Recruiting

BMT-CARE

Sponsor:

Massachusetts General Hospital

Code:

NCT06472089

Conditions

Bone Marrow Transplant Complications

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMT-CARE

Usual Care

Study Details

Brief 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.

Conditions

Bone Marrow Transplant Complications

Hematologic Malignancy

Study ID

NCT06472089

Start date

Jan 10, 2025

Status verified date

Oct, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

BMT-CARE

Therapist-delivered psychosocial intervention comprised of 6 sessions

Usual Care

Meeting a transplant social worker prior to HCT and as needed for extra visits

Primary outcome measure

  • Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire [ Time Frame: Up to 60 days post-HCT ]

Central Contacts and Locations

Central contacts

Areej El-Jawahri, MD

617-721-4000ael-jawahri@mgb.org

Jamie Jacobs, PhD

617-724-4000jjacobs@mgh.harvard.edu

Locations

University of Alabama at Brimingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

James Dionne-Odom

205-934-7597dionneod@uab.edu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Heather Jim

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

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Areej El-Jawahri, MD

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

Principal Investigator:

Areej El-Jawahri, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Keywords

  • Neoplasms by Site
  • Hematologic Diseases
  • Neoplasms
  • Hematologic Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-15.