BMT-CARE: Psychosocial Intervention for Transplant Caregivers
NCT Number: NCT06472089
Acronym: BMT-CARE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bone Marrow Transplant Complications|Hematologic Malignancy
Interventions: BEHAVIORAL: BMT-CARE|BEHAVIORAL: Usual Care
Sponsor: Massachusetts General Hospital
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2029-02
Locations: University of Alabama at Brimingham, Birmingham, Alabama, 35294, United States|Moffitt Cancer Center, Tampa, Florida, 33612, United States|Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States

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.

Primary Outcome Measures: Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire, 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, Up to 60 days post-HCT
Secondary Outcome Measures: Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire, 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, Up to 180 days post-HCT|Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire, 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, Up to 180 days post-HCT|Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale, 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, Up to 180 days post-HCT|Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale, 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, Up to 180 days post-HCT|Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire, 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, Up to 180 days post HCT|Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire, 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, Up to 180 days post-HCT
Other Outcome Measures: Patient quality of life as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire, Compare patient QOL as measured by the FACT-BMT between the two study groups. Score range 0-196 and higher scores indicate better QOL, Up to 180 days post-HCT|Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale, Compare patient 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, Up to 180 days post-HCT|Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale, Compare patient 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, Up to 180 days post-HCT|Patient symptom burden as measured by the Revised Edmonton Symptom Assessment Scale -Revised (ESAS-r), Compare patient symptom burden as measured by the ESAS-r between the study groups. Scor range 0-100 and higher scores indicate worse symptom burden., Up to 180 days post-HCT|Patient medication adherence as measured by the Medication Adherence Report Scale (MARS-5), Compare patient medication adherence as measured by the MARS-5 between study groups. Score range 5-25 with higher scors indicating better adherence., Up to 180 days post HCT|Rate of caregiver healthcare utilization as self-reported by caregivers, Compare Rates of caregiver healthcare utilization (e.g., hospitalizations, emergency department visits) between study groups., At 180 days post HCT|Rate of caregiver adherence to primary care visits and age-appropriate cancer screening as self-reported by caregivers, Compare rates of caregiver adherence to primary care visits and age-appropriate cancer screening between study groups, At 180 days post HCT|Rates of caregiver mental health resources utilization as self-reported by caregivers, Compare rates of caregiver mental health resource utilization between study groups, At day 180 post HCT|Rate of patient healthcare utilization as self-reported by patients and extracted from the electronic medical record, Compare rates of patient healthcare utilization (eg., hospitalizations, emergency department visits) between the study groups., At 180 days post HCT|Rates of patient mental health resources utilization as self-reported by patients, Compare rates of patient mental health resource utilization between study groups, At day 180 post HCT|Rates of acute and/or chronic graft-versus host disease based on data gathered from the electronic medical record, Compare the rates of acute and/or chronic graft-versus-host disease between study groups, At day 180 post HCT