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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Alabama
University of Alabama at Brimingham
RECRUITING
Birmingham
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Massachusetts
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Contact Information
Primary
Areej El-Jawahri, MD
ael-jawahri@mgb.org
617-721-4000
Backup
Jamie Jacobs, PhD
jjacobs@mgh.harvard.edu
617-724-4000
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2029-02
Participants
Target number of participants: 800
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov