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NCT Number: NCT05709912

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bone Marrow Transplant Complications Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARE Application

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The Leukemia and Lymphoma Society

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Feb 2, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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