Well-being of Caregivers (Caregiver Strain Index)
Conditions
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.
Interventions
OTHERhome care
This is the interventional arm where patients receive the transplant care in their homes.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | 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 |
| Rates of Fungal Infections | 1 year |
Countries
United States
Contacts
Primary ContactAndrea Pires, MS
Outcome results
None listed