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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
800
Therapist-delivered psychosocial intervention comprised of 6 sessions
Meeting a transplant social worker prior to HCT and as needed for extra visits
University of Alabama at Brimingham
Birmingham, Alabama, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGMassachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
RECRUITINGCaregiver 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-HCT
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-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
Time frame: 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
Time frame: 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
Time frame: Up to 180 days post-HCT
Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire
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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
Time frame: 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
Time frame: Up to 180 days post-HCT