BMT-CARE: Psychosocial Intervention for Transplant Caregivers

NCT06472089 | Recruiting DMC

• 1 other identifier: 24-013
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 3

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

Keywords

Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 60 days post-HCT

Secondary Outcomes (6)

• Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire

  Up to 180 days post-HCT

• Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire

  Up to 180 days post-HCT

• Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale

  Up to 180 days post-HCT

• Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale

  Up to 180 days post-HCT

• Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire

  Up to 180 days post HCT

Other Outcomes (11)

• Patient quality of life as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire

  Up to 180 days post-HCT

• Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale

  Up to 180 days post-HCT

• Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale

  Up to 180 days post-HCT

Study Arms (2)

BMT-CARE

EXPERIMENTAL

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.

Behavioral: BMT-CARE

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

BMT-CARE BEHAVIORAL

Therapist-delivered psychosocial intervention comprised of 6 sessions

BMT-CARE

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

University of Alabama at Brimingham

Birmingham, Alabama, 35294, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms by Site; Hematologic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jamie Jacobs, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Areej El-Jawahri, MD

CONTACT

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

Jamie Jacobs, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 24, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (3)