NCT03667599

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2018Jan 2027

First Submitted

Initial submission to the registry

July 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 28, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Expected
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

7.3 years

First QC Date

July 3, 2018

Last Update Submit

March 13, 2025

Conditions

Well-being of Caregivers (Caregiver Strain Index)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (38)

  • 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

  • +33 more secondary outcomes

Study Arms (3)

Home care

EXPERIMENTAL

This is the arm for patients who receive their transplant care in their homes.

Other: home care

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.

Interventions

home careOTHER

This is the interventional arm where patients receive the transplant care in their homes.

Home care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Interventions

Home Care Services

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Officials

  • Anthony Sung, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

  • Nelson Chao, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Pires, MS

CONTACT

919-613-1546andrea.pires@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

September 12, 2018

Study Start

September 28, 2018

Primary Completion

January 31, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

US(1)