BMT-CARE: Psychosocial Intervention for Transplant Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMT-CARE, Usual Care.
- Who it may be relevant to
- Registry conditions: Bone Marrow Transplant Complications, Hematologic Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
Overview
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.
Interventions
- Behavioral BMT-CARE
Therapist-delivered psychosocial intervention comprised of 6 sessions - Behavioral Usual Care
Meeting a transplant social worker prior to HCT and as needed for extra visits
Primary outcome measures
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire [Time frame: Up to 60 days post-HCT]
Secondary outcome measures (6)
- Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire [Time frame: Up to 180 days post-HCT]
- Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire [Time frame: Up to 180 days post-HCT]
- Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale [Time frame: Up to 180 days post-HCT]
- Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale [Time frame: Up to 180 days post-HCT]
- Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire [Time frame: Up to 180 days post HCT]
- Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire [Time frame: Up to 180 days post-HCT]
Eligibility criteria
Caregiver 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.
Caregiver 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- University of Alabama at Brimingham — Birmingham
- Moffitt Cancer Center — Tampa
- Massachusetts General Hospital Cancer Center — Boston
Identifiers
NCT: NCT06472089 · 24-013