Psychosocial support for caregivers of bone marrow transplant patients
Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
This study is testing a new support program for caregivers of bone marrow transplant patients to see if it can help them feel better and cope with stress during the recovery process.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT06472089 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a psychosocial intervention called BMT-CARE aimed at improving the quality of life and reducing distress among caregivers of patients undergoing hematopoietic cell transplant (HCT). Participants will be randomly assigned to receive either the BMT-CARE intervention along with usual care or just the usual care. The study will involve approximately 400 caregivers and 400 patients, with participation lasting up to 180 days post-transplant. The research is supported by the National Institutes of Health and aims to identify barriers and facilitators for implementing the BMT-CARE intervention.
Who should consider this trial
Good fit: Ideal candidates include adult caregivers of patients with hematologic malignancies who are receiving HCT and can communicate in English or Spanish.
Not a fit: Patients who are undergoing HCT for benign conditions or those who cannot provide informed consent due to psychiatric or cognitive issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the well-being of caregivers, leading to better support for patients undergoing HCT.
How similar studies have performed: Previous studies have shown that psychosocial interventions can improve caregiver outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 2 other locations
- University of Alabama at Brimingham — Birmingham, Alabama, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Areej El-Jawahri, MD — Massachusetts General Hospital
- Study coordinator: Areej El-Jawahri, MD
- Email: ael-jawahri@mgb.org
- Phone: 617-721-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.