BMT-CARE: Psychosocial Intervention for Transplant Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic HCT.
Trial design
Design model
Parallel
Treatments tested in this trial
BMT-CARE
BehavioralTherapist-delivered psychosocial intervention comprised of 6 sessions
Usual Care
BehavioralMeeting a transplant social worker prior to HCT and as needed for extra visits
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: BMT-CAREExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 60 days post-HCTSecondary outcomes
1
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
Time frame
Up to 180 days post-HCT2
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
Time frame
Up to 180 days post-HCT3
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
Time frame
Up to 180 days post-HCT4
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
Time frame
Up to 180 days post-HCTOther outcomes
1
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
Time frame
Up to 180 days post-HCT2
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
Time frame
Up to 180 days post-HCT3
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
Time frame
Up to 180 days post-HCT4
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.
Time frame
Up to 60 days post-HCTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov