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

November 16, 2025 updated by: El-Jawahri, Areej,M.D., Massachusetts General Hospital

Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Caregivers of Patients Receiving Hematopoietic Cell Transplantation (HCT)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized clinical trial to determine whether a 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). The CARE app was developed with the goal of addressing the needs of caregivers of HCT recipients.

Participants will be randomized into one of two study groups: CARE app plus Usual Care versus Usual Care.

Participation in this study is expected to last up to 100 days after HCT.

It is expected that about 120 people will take part in this research study.

The Leukemia and Lymphoma Society is supporting this research by providing funding.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Caregiver Inclusion Criteria:

  • 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

Patient Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CARE App

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
Self-administered, psychosocial mobile application comprised of 5 learning modules.
Active Comparator: Usual Care

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

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
Time Frame: up to 60 days post-HCT
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
Time Frame: up to 100 days post HCT
Compare caregiver QOL as measured by the CARGOQOL between the two study groups longitudinally. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
up to 100 days post HCT
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA)
Time Frame: Up to 100 days post HCT
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 100 days post HCT
Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety)
Time Frame: Up to 100 days post HCT
Compare 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 100 days post HCT
Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
Time Frame: Up to 100 days post HCT
Compare 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 100 days post HCT
Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist
Time Frame: Up to 100 days post HCT
Compare post-traumatic stress symptoms as measured by the Post-Traumatic Stress Checklist-Civilian Version between the two groups. The checklist ranges from 17-85 with higher scores indicating worse PTSD Symptoms
Up to 100 days post HCT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping as measured by the Measure of Current Status (MOCS)
Time Frame: Up to 100 days post-HCT
Comparing caregiver coping as measured by the MOCS between the two study groups. The scale ranges from 0-52 with higher scores indicating higher coping skills
Up to 100 days post-HCT
Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale
Time Frame: Up to 100 days post-HCT
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 100 days post-HCT
Usability of the CARE app using the System Usability Scale
Time Frame: up to 60 days post-HCT
Assess the usability of the care app (in those receiving the intervention) using the System Usability Scale, which ranges 0-100 with higher scores indicating better usability
up to 60 days post-HCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

The Leukemia and Lymphoma Society

Investigators

  • Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-634

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe