Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Caregivers of Patients Receiving Hematopoietic Cell Transplantation (HCT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Study Overview
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).
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
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
Arms & Interventions
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
Intervention: CARE Application (Behavioral)
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.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Time Frame: up to 60 days post-HCT
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
Secondary Outcomes
- Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)(Up to 100 days post HCT)
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire(up to 100 days post HCT)
- Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety)(Up to 100 days post HCT)
- Caregiving burden as measured by the Caregiver Reaction Assessment (CRA)(Up to 100 days post HCT)
- Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist(Up to 100 days post HCT)
Investigators
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital