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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-12-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bone Marrow Transplant Complications Hematologic Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

CARE Application

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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CARE Application

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

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No