Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant

NCT05709912 | Active Not Recruiting

• 1 other identifier: 22-634
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to determine whether a self-administered, psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT).

Conditions

Bone Marrow Transplant Complications; Hematologic Malignancy

Keywords

Cognitive Behavioral Therapy; CBT; Hematopoietic stem cell transplantation; HCT; Bone Marrow Transplant Complications; Hematologic Malignancy

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 (5)

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

  up to 100 days post HCT

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

  Up to 100 days post HCT

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

  Up to 100 days post HCT

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

  Up to 100 days post HCT

• Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist

  Up to 100 days post HCT

Other Outcomes (3)

• Coping as measured by the Measure of Current Status (MOCS)

  Up to 100 days post-HCT

• Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale

  Up to 100 days post-HCT

• Usability of the CARE app using the System Usability Scale

  up to 60 days post-HCT

Study Arms (2)

CARE App

EXPERIMENTAL

Participants randomized to the CARE app + usual care will complete the following: * Questionnaires at baseline, Day 10, Day 60, and Day 100 post-HCT * use the CARE app from enrollment up to 60 days post-HCT: the CARE app includes 5 contains 5 modules and a 6th optional module * receive usual care as per HCT practice which entails meeting with a transplant social worker prior to HCT and as needed for extra visits

Behavioral: CARE Application

Usual Care

ACTIVE COMPARATOR

Participants randomized to usual care will complete the following: * Questionnaires at baseline, Day 10, Day 60, and Day 100. * receive usual care as per HCT practice, which entails meeting with a transplant social worker prior to HCT and as needed for extra visits.

Behavioral: Usual Care

Interventions

CARE Application BEHAVIORAL

Self-administered, psychosocial mobile application comprised of 5 learning modules.

CARE App

Usual Care BEHAVIORAL

Meeting with transplant social worker prior to HCT, consistent with standard-of-care.

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) who is a relative or friend who live with the patient or is a designated caregiver as indicated during the transplant process.
• Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer
• Ability to comprehend and speak English as the CARE app is only available in English

You may not qualify if:

• Caregivers of patients undergoing HCT for benign hematologic conditions
• Caregivers with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Willis KD, Barata A, Freese M, Applebaum AJ, Nelson A, Traeger LN, Horick NK, Rabideau DJ, Temel JS, Greer JA, Jacobs JM, El-Jawahri A. Randomised controlled trial of a psychosocial digital health application to promote coping for caregivers of patients undergoing haematopoietic stem cell transplantation: a study protocol for the BMT-CARE app. BMJ Open. 2025 Apr 8;15(4):e092371. doi: 10.1136/bmjopen-2024-092371.

  PMID: 40204300 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

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 (1)