A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home care This is the arm for patients who receive their transplant care in their homes. |
Other: home care
This is the interventional arm where patients receive the transplant care in their homes.
|
| No Intervention: Hospital Care Standard of care for stem cell transplant recipients where the aftercare is done in hospital. |
|
| No Intervention: Clinic Care Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic. |
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Anthony Sung, MD, Duke Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00089697