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

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709912
• Other study ID #: 22-634
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Areej El-Jawahri, MD
• Phone: 617-721-4000
• Email: ael-jawahri[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Transplant Complications
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Behavioral:
• CARE Application
Self-administered, psychosocial mobile application comprised of 5 learning modules.
• Usual Care
Meeting with transplant social worker prior to HCT, consistent with standard-of-care.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Coping as measured by the Measure of Current Status (MOCS)	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
Other	Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale	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
Other	Usability of the CARE app using the System Usability Scale	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
Primary	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	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 longitudinally. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL	up to 100 days post HCT
Secondary	Caregiving burden as measured by the Caregiver Reaction Assessment (CRA)	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
Secondary	Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety)	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
Secondary	Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)	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
Secondary	Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist	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