NCT03667599 · Duke University
A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
What this study is about
This is a research study to compare the well-being (caregiver strain index) of caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.
View original scientific description
This is a research study to compare the well-being (caregiver strain index) of caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.
Interventions
OTHER
home care
This is the interventional arm where patients receive the transplant care in their homes.
Primary outcome measures
Quality of Life in Caregivers (Caregiver Strain Index)
Time frame: 14 days
To compare the quality of life (Caregiver Strain Index) in caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2025 · Source of record for eligibility and locations