Comparing caregiver well-being after home care versus standard care post-stem cell transplant
A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
NA · Duke University · NCT03667599
This study is testing whether caregivers of patients who have had a stem cell transplant feel less stressed and better overall when they provide home care compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT03667599 on ClinicalTrials.gov |
What this trial studies
This research focuses on evaluating the well-being of caregivers who provide support to patients undergoing autologous hematopoietic stem cell transplantation. The study compares the caregiver strain index between those receiving home care and those receiving standard care following the transplant. Participants must be within a suitable distance from Duke University Medical Center and meet specific health criteria. The goal is to assess how different care settings impact caregiver stress and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 scheduled for autologous hematopoietic stem cell transplantation with a caregiver.
Not a fit: Patients without a caregiver or those with active infections prior to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved support strategies for caregivers, enhancing their well-being during a challenging time.
How similar studies have performed: While caregiver well-being studies exist, this specific comparison of home care versus standard care post-transplant is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion Criteria: * Scheduled to undergo an autologous hematopoietic stem cell transplant for any cancer or non-cancer illness * Age 18-80 years * Karnofsky Performance Scale KPS\> 80 * Able to read/write English * A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke Patient Exclusion Criteria: * Lack of a caregiver * Pregnant women * Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection. * Use of homeopathic medications, prebiotics, or probiotics that may impact gut microbiota Caregiver Inclusion Criteria: * Identified by patient as their primary caregiver * Meet standard clinical criteria for being a caregiver (able to drive and take care of patient) * Age 18-80 years Caregiver Exclusion Criteria: None
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Anthony Sung, MD — Duke Health
- Study coordinator: Andrea Pires, MS
- Email: andrea.pires@duke.edu
- Phone: 919-613-1546
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.
Conditions: Well-being of Caregivers