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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Well-being of Caregivers (Caregiver Strain Index)
• Intervention / Treatment: Other: home care

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Pires, MS; Phone Number: 919-613-1546; Email: andrea.pires@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Contact: Anthony Sung, MD; Phone Number: 919-668-5710; Email: anthony.sung@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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	Time Frame
Overall Survival	1 year
Disease Free Survival	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
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Anthony Sung, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: Pro00089697

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No