BMT-CARE: Psychosocial Intervention for Transplant Caregivers (BMT-CARE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy; Bone Marrow Transplant Complications
• Intervention / Treatment: Behavioral: BMT-CARE; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Areej El-Jawahri, MD; Phone Number: 617-721-4000; Email: ael-jawahri@mgb.org
• Study Contact Backup: Name: Jamie Jacobs, PhD; Phone Number: 617-724-4000; Email: jjacobs@mgh.harvard.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Brimingham
      • Contact: James Dionne-Odom; Phone Number: 205-934-7597; Email: dionneod@uab.edu
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Heather Jim; Phone Number: 813-745-6369; Email: heather.jim@moffitt.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Areej El-Jawahri, MD; Phone Number: 617-643-4003; Email: AEL-JAWAHRI@PARTNERS.ORG
      • Principal Investigator: Areej El-Jawahri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: BMT-CARE; Therapist-delivered psychosocial intervention comprised of 6 sessions
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.	Behavioral: Usual Care; Meeting a transplant social worker prior to HCT and as needed for extra visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 180 days post-HCT
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire	Compare caregiving burden as measured by the CRA between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden	Up to 180 days post-HCT
Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale	Compare caregiver depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms	Up to 180 days post-HCT
Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale	Compare caregiver anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse anxiety symptoms	Up to 180 days post-HCT
Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire	Compare caregiver coping as measured by the MOCS-A between the two study groups. The scale ranges from 0-52 with higher scores indicating higher coping skills	Up to 180 days post HCT
Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire	Compare caregiver self-efficacy as measured by the CASE-t between the two study groups. The scale ranges from 0-170 with higher scores indicating better self-efficacy	Up to 180 days post-HCT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient quality of life as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire	Compare patient QOL as measured by the FACT-BMT between the two study groups. Score range 0-196 and higher scores indicate better QOL	Up to 180 days post-HCT
Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale	Compare patient depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms	Up to 180 days post-HCT
Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale	Compare patient anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse anxiety symptoms	Up to 180 days post-HCT
Patient medication adherence as measured by the Medication Adherence Report Scale (MARS-5)	Compare patient medication adherence as measured by the MARS-5 between study groups. Score range 5-25 with higher scors indicating better adherence.	Up to 180 days post HCT
Rate of caregiver healthcare utilization as self-reported by caregivers	Compare Rates of caregiver healthcare utilization (e.g., hospitalizations, emergency department visits) between study groups.	At 180 days post HCT
Rate of caregiver adherence to primary care visits and age-appropriate cancer screening as self-reported by caregivers	Compare rates of caregiver adherence to primary care visits and age-appropriate cancer screening between study groups	At 180 days post HCT
Rates of caregiver mental health resources utilization as self-reported by caregivers	Compare rates of caregiver mental health resource utilization between study groups	At day 180 post HCT
Rate of patient healthcare utilization as self-reported by patients and extracted from the electronic medical record	Compare rates of patient healthcare utilization (eg., hospitalizations, emergency department visits) between the study groups.	At 180 days post HCT
Rates of patient mental health resources utilization as self-reported by patients	Compare rates of patient mental health resource utilization between study groups	At day 180 post HCT
Rates of acute and/or chronic graft-versus host disease based on data gathered from the electronic medical record	Compare the rates of acute and/or chronic graft-versus-host disease between study groups	At day 180 post HCT
Patient symptom burden as measured by the Revised Edmonton Symptom Assessment Scale -Revised (ESAS-r)	Compare patient symptom burden as measured by the ESAS-r between the study groups. Scor range 0-100 and higher scores indicate worse symptom burden.	Up to 60 days post-HCT

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital; Principal Investigator: Jamie Jacobs, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 22, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Neoplasms; Hematologic Diseases; Hematologic Neoplasms; Neoplasms by Site
• Additional Relevant MeSH Terms: Hemic and Lymphatic Diseases; Neoplasms; Hematologic Neoplasms; Hematologic Diseases; Neoplasms by Site
• Other Study ID Numbers: 24-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No