RecruitingNot ApplicableNCT03667599

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


Sponsor

Duke University

Enrollment

150 participants

Start Date

Sep 28, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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
  • 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

Exclusion Criteria5

  • 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
  • None

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Interventions

OTHERhome care

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


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT03667599