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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
GroupInterventionDescription
Home carehome careThis is the arm for patients who receive their transplant care in their homes.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Measuring Caregiver Quality of Life as assessed by the FACT-GP1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety1 year
Measuring Caregiver Burden as recorded in a Time Diary1 year
Measuring Caregiver Self-Efficacy assessed by the Modified Lorig1 year
Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction1 year
Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health1 year
Measuring Return to Work in Caregivers (Work Assessment)1 year
Disease Free Survival1 year
Rates of Viral Infections1 year
Measuring Caregiver Mental Health as assessed by the PROMIS-Depression1 year
Overall Survival1 year
Measuring Quality of Life as assessed by the EQ-5D-5L1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep1 year
Rates of Overall Infections1 year
Rates of Fungal Infections1 year
Measuring Mental Health as assessed by the PROMIS-Anxiety1 year
Measuring Mental Health as assessed by the PROMIS-Depression1 year
Measuring Return to Work as assessed by the Work Assessment1 year
Measuring Nutrition as assessed by the PG-SGA30 days
Rates of Bacterial Infections1 year
Measuring Self-Efficacy as assessed by the Lorig1 year
Measuring Out-of-Pocket Costs as recorded in a Cost Diary1 year
Measuring Exercise as assessed by 6 minute walk test1 year
Measuring Changes in fecal samples as measured by 16s rRNA sequencing1 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 scale1 year
Measuring Fatigue as assessed by the PROMIS-Sleep1 year
Measuring Changes in the skin flora (microbiome)1 year
Measuring Direct Medical Costs6 months
Measuring Fatigue as assessed by the PROMIS-Fatigue1 year
Measuring treatment related mortality (TRM)1 year
Measuring Health Resource Utilization using Duke University Health System (DUHS) records1 year
Measuring Social Support as assessed by the PROMIS-Social Isolation1 year
Rates of Hospital Admission1 year
Transplant Length of Stay1 year
Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue1 year
Measuring Hand Grip Strength1 year

Trial Locations

Locations (1)

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

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