Clinical trial NCT03667599: A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
Official title: A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-being of Caregivers (Caregiver Strain Index)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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 Exclusion Criteria:

None

Primary outcomes:
measure: Quality of Life in Caregivers (Caregiver Strain Index)
timeFrame: 14 days
Secondary outcomes:
measure: Measuring Caregiver Burden as recorded in a Time Diary
timeFrame: 1 year
measure: Measuring Caregiver Self-Efficacy assessed by the Modified Lorig
timeFrame: 1 year
measure: Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction
timeFrame: 1 year
measure: Measuring Caregiver Quality of Life as assessed by the FACT-GP
timeFrame: 1 year
measure: Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health
timeFrame: 1 year
measure: Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue
timeFrame: 1 year
measure: Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep
timeFrame: 1 year
measure: Measuring Caregiver Mental Health as assessed by the PROMIS-Depression
timeFrame: 1 year
measure: Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety
timeFrame: 1 year
measure: Measuring Return to Work in Caregivers (Work Assessment)
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
measure: Disease Free Survival
timeFrame: 1 year
measure: Rates of Overall Infections
timeFrame: 1 year
measure: Rates of Bacterial Infections
timeFrame: 1 year
measure: Rates of Viral Infections
timeFrame: 1 year
measure: Rates of Fungal Infections
timeFrame: 1 year
measure: Rates of Hospital Admission
timeFrame: 1 year
measure: Transplant Length of Stay
timeFrame: 1 year
measure: Measuring Quality of Life as assessed by the EQ-5D-5L
timeFrame: 1 year
measure: Measuring Symptoms as assessed by MDASI scale
timeFrame: 1 year
measure: Measuring Self-Efficacy as assessed by the Lorig
timeFrame: 1 year
measure: Measuring Fatigue as assessed by the PROMIS-Fatigue
timeFrame: 1 year
measure: Measuring Fatigue as assessed by the PROMIS-Sleep
timeFrame: 1 year
measure: Measuring Mental Health as assessed by the PROMIS-Anxiety
timeFrame: 1 year
measure: Measuring Mental Health as assessed by the PROMIS-Depression
timeFrame: 1 year
measure: Measuring Out-of-Pocket Costs as recorded in a Cost Diary
timeFrame: 1 year
measure: Measuring Return to Work as assessed by the Work Assessment
timeFrame: 1 year
measure: Measuring Social Support as assessed by the PROMIS-Social Isolation
timeFrame: 1 year
measure: Measuring Nutrition as assessed by the PG-SGA
timeFrame: 30 days
measure: Measuring Hand Grip Strength
timeFrame: 1 year
measure: Measuring Exercise as assessed by 6 minute walk test
timeFrame: 1 year
measure: Measuring Changes in fecal samples as measured by 16s rRNA sequencing
timeFrame: 1 year
measure: Measuring Changes in the skin flora (microbiome)
timeFrame: 1 year
measure: Measuring treatment related mortality (TRM)
timeFrame: 1 year
measure: Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
timeFrame: 1 year
measure: Measuring Direct Medical Costs
timeFrame: 6 months
measure: Measuring Health Resource Utilization using Duke University Health System (DUHS) records
timeFrame: 1 year
measure: Measuring Indirect Costs (Patient's and Caregivers' Time)
timeFrame: 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Anthony Sung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Health
name: Nelson Chao, MD
role: PRINCIPAL_INVESTIGATOR
References: