A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
Not Applicable
Recruiting
- Conditions
- Well-being of Caregivers (Caregiver Strain Index)
- Interventions
- Other: home care
- Registration Number
- NCT03667599
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home care home care This is the arm for patients who receive their transplant care in their homes.
- Primary Outcome Measures
Name Time Method Quality of Life in Caregivers (Caregiver Strain Index) 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 Outcome Measures
Name Time Method Measuring Caregiver Quality of Life as assessed by the FACT-GP 1 year Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety 1 year Measuring Caregiver Burden as recorded in a Time Diary 1 year Measuring Caregiver Self-Efficacy assessed by the Modified Lorig 1 year Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction 1 year Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health 1 year Measuring Return to Work in Caregivers (Work Assessment) 1 year Disease Free Survival 1 year Rates of Viral Infections 1 year Measuring Caregiver Mental Health as assessed by the PROMIS-Depression 1 year Overall Survival 1 year Measuring Quality of Life as assessed by the EQ-5D-5L 1 year Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep 1 year Rates of Overall Infections 1 year Rates of Fungal Infections 1 year Measuring Mental Health as assessed by the PROMIS-Anxiety 1 year Measuring Mental Health as assessed by the PROMIS-Depression 1 year Measuring Return to Work as assessed by the Work Assessment 1 year Measuring Nutrition as assessed by the PG-SGA 30 days Rates of Bacterial Infections 1 year Measuring Self-Efficacy as assessed by the Lorig 1 year Measuring Out-of-Pocket Costs as recorded in a Cost Diary 1 year Measuring Exercise as assessed by 6 minute walk test 1 year Measuring Changes in fecal samples as measured by 16s rRNA sequencing 1 year Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 1 year Measuring Indirect Costs (Patient's and Caregivers' Time) 1 year Measuring Symptoms as assessed by MDASI scale 1 year Measuring Fatigue as assessed by the PROMIS-Sleep 1 year Measuring Changes in the skin flora (microbiome) 1 year Measuring Direct Medical Costs 6 months Measuring Fatigue as assessed by the PROMIS-Fatigue 1 year Measuring treatment related mortality (TRM) 1 year Measuring Health Resource Utilization using Duke University Health System (DUHS) records 1 year Measuring Social Support as assessed by the PROMIS-Social Isolation 1 year Rates of Hospital Admission 1 year Transplant Length of Stay 1 year Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue 1 year Measuring Hand Grip Strength 1 year
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States