Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant
- Conditions
- Bone Marrow Transplant ComplicationsHematologic Malignancy
- Interventions
- Behavioral: Usual CareBehavioral: CARE Application
- Registration Number
- NCT05709912
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care 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. CARE App CARE Application 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
- Primary Outcome Measures
Name Time Method Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire 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 Outcome Measures
Name Time Method Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) Up to 100 days post HCT Compare depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire up to 100 days post HCT Compare caregiver QOL as measured by the CARGOQOL between the two study groups longitudinally. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety) Up to 100 days post HCT Compare anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse anxiety symptoms
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) Up to 100 days post HCT Compare caregiving burden as measured by the CRA between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden
Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist Up to 100 days post HCT Compare post-traumatic stress symptoms as measured by the Post-Traumatic Stress Checklist-Civilian Version between the two groups. The checklist ranges from 17-85 with higher scores indicating worse PTSD Symptoms
Trial Locations
- Locations (1)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States