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Trial Title:
BMT-CARE: Psychosocial Intervention for Transplant Caregivers
NCT ID:
NCT06472089
Condition:
Bone Marrow Transplant Complications
Hematologic Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
Neoplasms by Site
Hematologic Diseases
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
BMT-CARE
Description:
Therapist-delivered psychosocial intervention comprised of 6 sessions
Arm group label:
BMT-CARE
Intervention type:
Behavioral
Intervention name:
Usual Care
Description:
Meeting a transplant social worker prior to HCT and as needed for extra visits
Arm group label:
Usual Care
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.
Criteria for eligibility:
Criteria:
Caregiver Inclusion Criteria:
- 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 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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Brimingham
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Contact:
Last name:
James Dionne-Odom
Email:
dionneod@uab.edu
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Contact:
Last name:
Heather Jim
Email:
heather.jim@moffitt.org
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02114
Country:
United States
Start date:
October 2024
Completion date:
February 2029
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06472089
