Duke University Medical Center
Durham, North Carolina, 27705, United States
Location status: Recruiting
Recruiting
NCT Number: NCT03667599
A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Home care
OtherThis is the interventional arm where patients receive the transplant care in their homes.
Primary outcomes
-
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.
Secondary outcomes
-
Measuring Caregiver Burden as recorded in a Time Diary
Time frame: 1 year
-
Measuring Caregiver Self-Efficacy assessed by the Modified Lorig
Time frame: 1 year
-
Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction
Time frame: 1 year
-
Measuring Caregiver Quality of Life as assessed by the FACT-GP
Time frame: 1 year
-
Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health
Time frame: 1 year
-
Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue
Time frame: 1 year
-
Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep
Time frame: 1 year
-
Measuring Caregiver Mental Health as assessed by the PROMIS-Depression
Time frame: 1 year
-
Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety
Time frame: 1 year
-
Measuring Return to Work in Caregivers (Work Assessment)
Time frame: 1 year
-
Overall Survival
Time frame: 1 year
-
Disease Free Survival
Time frame: 1 year
-
Rates of Overall Infections
Time frame: 1 year
-
Rates of Bacterial Infections
Time frame: 1 year
-
Rates of Viral Infections
Time frame: 1 year
-
Rates of Fungal Infections
Time frame: 1 year
-
Rates of Hospital Admission
Time frame: 1 year
-
Transplant Length of Stay
Time frame: 1 year
-
Measuring Quality of Life as assessed by the EQ-5D-5L
Time frame: 1 year
-
Measuring Symptoms as assessed by MDASI scale
Time frame: 1 year
-
Measuring Self-Efficacy as assessed by the Lorig
Time frame: 1 year
-
Measuring Fatigue as assessed by the PROMIS-Fatigue
Time frame: 1 year
-
Measuring Fatigue as assessed by the PROMIS-Sleep
Time frame: 1 year
-
Measuring Mental Health as assessed by the PROMIS-Anxiety
Time frame: 1 year
-
Measuring Mental Health as assessed by the PROMIS-Depression
Time frame: 1 year
-
Measuring Out-of-Pocket Costs as recorded in a Cost Diary
Time frame: 1 year
-
Measuring Return to Work as assessed by the Work Assessment
Time frame: 1 year
-
Measuring Social Support as assessed by the PROMIS-Social Isolation
Time frame: 1 year
-
Measuring Nutrition as assessed by the PG-SGA
Time frame: 30 days
-
Measuring Hand Grip Strength
Time frame: 1 year
-
Measuring Exercise as assessed by 6 minute walk test
Time frame: 1 year
-
Measuring Changes in fecal samples as measured by 16s rRNA sequencing
Time frame: 1 year
-
Measuring Changes in the skin flora (microbiome)
Time frame: 1 year
-
Measuring treatment related mortality (TRM)
Time frame: 1 year
-
Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: 1 year
-
Measuring Direct Medical Costs
Time frame: 6 months
-
Measuring Health Resource Utilization using Duke University Health System (DUHS) records
Time frame: 1 year
-
Measuring Indirect Costs (Patient's and Caregivers' Time)
Time frame: 1 year
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Duke University
Other
Registry information
Official study title
A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
Important dates
- Study start
- 2018
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Sep 12, 2018
- Registry last updated
- Mar 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.