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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home care | Experimental | This is the arm for patients who receive their transplant care in their homes. |
|
| Hospital Care | No Intervention | Standard of care for stem cell transplant recipients where the aftercare is done in hospital. | |
| Clinic Care | No Intervention | Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home care | Other | This is the interventional arm where patients receive the transplant care in their homes. |
|
| 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 |
| 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 |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
None
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pires, MS | Contact | 919-613-1546 | andrea.pires@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anthony Sung, MD | Duke Health | Principal Investigator |
| Nelson Chao, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D006699 | Home Care Services |
| ID | Term |
|---|---|
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009739 | Nursing Services |
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| 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 |