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NCT05709912 | Recruiting | Bone Marrow Transplant Complications


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

Massachusetts General Hospital

Information provided by (Responsible Party):

El-Jawahri, Areej, M.D.

Brief 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).

Condition or disease

Bone Marrow Transplant Complications

Hematologic Malignancy

Intervention/treatment

CARE Application

Usual Care

Phase

Not Applicable

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
Estimated Enrollment : 120 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Caregivers of Patients Receiving Hematopoietic Cell Transplantation (HCT)
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2025
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

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

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02215

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