A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation

Conditions
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Well-being of Caregivers (Caregiver Strain Index)

Intervention / Treatment
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* Other: home care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home care<br>This is the arm for patients who receive their transplant care in their homes. | Other: home care<br>* This is the interventional arm where patients receive the transplant care in their homes.<br>|
| No Intervention: Hospital Care<br>Standard of care for stem cell transplant recipients where the aftercare is done in hospital. | |
| No Intervention: Clinic Care<br>Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in Caregivers (Caregiver Strain Index) | To compare the quality of life (Caregiver Strain Index) in caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 FACT-GP |  | 1 year | 
| Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health |  | 1 year | 
| Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue |  | 1 year | 
| Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep |  | 1 year | 
| Measuring Caregiver Mental Health as assessed by the PROMIS-Depression |  | 1 year | 
| Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety |  | 1 year | 
| Measuring Return to Work in Caregivers (Work Assessment) |  | 1 year | 
| Overall Survival |  | 1 year | 
| Disease Free Survival |  | 1 year | 
| Rates of Overall Infections |  | 1 year | 
| Rates of Bacterial Infections |  | 1 year | 
| Rates of Viral Infections |  | 1 year | 
| Rates of Fungal Infections |  | 1 year | 
| Rates of Hospital Admission |  | 1 year | 
| Transplant Length of Stay |  | 1 year | 
| Measuring Quality of Life as assessed by the EQ-5D-5L |  | 1 year | 
| Measuring Symptoms as assessed by MDASI scale |  | 1 year | 
| Measuring Self-Efficacy as assessed by the Lorig |  | 1 year | 
| Measuring Fatigue as assessed by the PROMIS-Fatigue |  | 1 year | 
| Measuring Fatigue as assessed by the PROMIS-Sleep |  | 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 Out-of-Pocket Costs as recorded in a Cost Diary |  | 1 year | 
| Measuring Return to Work as assessed by the Work Assessment |  | 1 year | 
| Measuring Social Support as assessed by the PROMIS-Social Isolation |  | 1 year | 
| Measuring Nutrition as assessed by the PG-SGA |  | 30 days | 
| Measuring Hand Grip Strength |  | 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 Changes in the skin flora (microbiome) |  | 1 year | 
| Measuring treatment related mortality (TRM) |  | 1 year | 
| Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) |  | 1 year | 
| Measuring Direct Medical Costs |  | 6 months | 
| Measuring Health Resource Utilization using Duke University Health System (DUHS) records |  | 1 year | 
| Measuring Indirect Costs (Patient's and Caregivers' Time) |  | 1 year |