Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bone Marrow Transplant Complications
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 800
- Locations
- 3
- Primary Endpoint
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption.
Detailed Description
This is a randomized clinical trial to determine whether a psychosocial intervention (BMT-CARE) is effective at improving the quality of life and reducing psychosocial distress of caregivers and patients treated with hematopoietic cell transplant (HCT). The BMT-CARE intervention was developed with the goal of improving the experience and needs of caregivers of patients treated with HCT. Caregivers will be randomized into one of the two study groups: BMT-CARE plus usual care, or usual care. Participation in this study is expected to last up to 180 days after HCT. Investigators expect that about 400 caregivers and up to 400 patients treated with HCT will take part in this research study. The National Institutes of Health is supporting this research by providing funding.
Investigators
El-Jawahri, Areej,M.D.
Associate Professor of Medicine
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Adult caregivers (≥18 years) relative or friend of a patient identified as living with them or having in-person contact with them at least twice a week.
- •Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer.
- •Ability to read and respond to survey questions in English, Spanish or with minimal assistance from an interpreter.
Exclusion Criteria
- •Caregivers of patients undergoing HCT for a benign hematologic condition or undergoing outpatient HCT.
- •Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
- •Caregivers of patients who have already undergone HCT within the past 5 years
- •Patient Inclusion Criteria:
- •Adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic HCT.
- •Ability to respond to questions in English, Spanish, or with minimal assistance from an interpreter.
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
- Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire(Up to 180 days post-HCT)
- Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale(Up to 180 days post-HCT)
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire(Up to 180 days post-HCT)
- Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale(Up to 180 days post-HCT)
- Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire(Up to 180 days post-HCT)
- Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire(Up to 180 days post HCT)