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Trial Title:
Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant
NCT ID:
NCT05709912
Condition:
Bone Marrow Transplant Complications
Hematologic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
Cognitive Behavioral Therapy
CBT
Hematopoietic stem cell transplantation
HCT
Bone Marrow Transplant Complications
Hematologic Malignancy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CARE Application
Description:
Self-administered, psychosocial mobile application comprised of 5 learning modules.
Arm group label:
CARE App
Intervention type:
Behavioral
Intervention name:
Usual Care
Description:
Meeting with transplant social worker prior to HCT, consistent with standard-of-care.
Arm group label:
Usual Care
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).
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Areej El-Jawahri, MD
Phone:
617-724-4000
Email:
ael-jawahri@partners.org
Start date:
July 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
The Leukemia and Lymphoma Society
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05709912
