Recruiting

Autologous Stem Cell Transplantation

Sponsor:

Duke University

Code:

NCT03667599

Conditions

Well-being of Caregivers (Caregiver Strain Index)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

home care

Study Details

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.

Conditions

Well-being of Caregivers (Caregiver Strain Index)

Study ID

NCT03667599

Start date

Sep 28, 2018

Status verified date

Mar, 2025

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Home care

This is the arm for patients who receive their 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.

Interventions

home care

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

Primary outcome measure

  • Quality of Life in Caregivers (Caregiver Strain Index) [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Andrea Pires, MS

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

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Anthony Sung, MD

919-668-5710anthony.sung@duke.edu

More Information

Sponsor

Duke University

Last update posted

Mar 17, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-03-17.