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

Mass General Brigham

Status: Active, not recruiting

Conditions: Hematologic Malignancy; Bone Marrow Transplant Complications

Treatments: Behavioral: CARE Application; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05709912

22-634

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

CARE App

Experimental group

Description:

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

Treatment:

Behavioral: CARE Application

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care