NCT01725022

Brief Summary

The primary goal with this study is to document whether patients can maintain their normal bowel microbiota by staying at home compared to those who live at home but are treated in clinic, and those who are treated in the hospital. In addition, the investigators would predict that the quality of life will be higher for those patients treated at the medical home compared to those that stay at the hospital. The investigators also predict that the costs associated with this approach will be significantly lower compared to hospitalized patients. Finally, the investigators propose that the treatment related morbidities and mortality will not be different between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

5.7 years

First QC Date

November 8, 2012

Last Update Submit

July 15, 2019

Conditions

Hematologic Malignancies

Keywords

stem cell transplantbowel microbiotahome care

Outcome Measures

Primary Outcomes (1)

  • Bowel Microbiota

    The bowel microbiota before and during the first 100 days.

    100 days

Secondary Outcomes (5)

  • Nutritional status using the PG-SGA assessment tool

    100 days

  • Incidence of acute Graft Versus Host Disease (GVHD)

    100 days

  • Treatment related morbidities and mortalities

    100 Days

  • Quality Of Life Assessment (QOL)

    100 Days

  • Costs of care

    100 Days

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 a hematopoietic stem cell transplant for any cancer or non-cancer illness from any autologous, related or unrelated donor source including bone marrow, peripheral blood progenitor cell, or umbilical cord blood
  • Age 18-80 years of age
  • Karnofsky Performance Scale (KPS) \> 80
  • A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke (home care group only)

You may not qualify if:

  • Lack of a caregiver
  • Pregnant women (It is standard of care to assess for pregnancy for all females of child-bearing potential with a serum beta human chorionic gonadotropin (HCG) test within 7 days of starting the preparative regimen prior to transplant. No additional research pregnancy testing will occur.)
  • Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Officials

  • Nelson Chao, MD, MBA

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 12, 2012

Study Start

February 1, 2012

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

US(1)