BMT-CARE: Psychosocial Intervention for Transplant Caregivers
- Conditions
- Hematologic MalignancyBone Marrow Transplant Complications
- Interventions
- Behavioral: Usual CareBehavioral: BMT-CARE
- Registration Number
- NCT06472089
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Adult caregivers (≥18 years) who is a relative or friend whom the 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.
Caregiver
- 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.
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.
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, and days 60, 90 and 180 post HCT. * Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits. BMT-CARE BMT-CARE Participants randomized to BMT-CARE plus usual care will complete the following: * Questionnaires at baseline, and days 60, 90 and 180 post HCT. * Receive the BMT-CARE intervention from enrollment up to 60 days post-HCT. BMT-CARE is a -6-session caregiver-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that integrates HCT-related education with CBT strategies to enhance caregiver knowledge and skills. * Receive usual care as per HCT practice which entails meeting 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 Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire Up to 180 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
Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale Up to 180 days post-HCT Compare caregiver 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
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire Up to 180 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
Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale Up to 180 days post-HCT Compare caregiver 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 self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire Up to 180 days post-HCT Compare caregiver self-efficacy as measured by the CASE-t between the two study groups. The scale ranges from 0-170 with higher scores indicating better self-efficacy
Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire Up to 180 days post HCT Compare caregiver coping as measured by the MOCS-A between the two study groups. The scale ranges from 0-52 with higher scores indicating higher coping skills
Trial Locations
- Locations (3)
University of Alabama at Brimingham
🇺🇸Birmingham, Alabama, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States