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

NCT ID: NCT03667599

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2027-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Well-being of Caregivers (Caregiver Strain Index)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Home care

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

Group Type EXPERIMENTAL

home care

Intervention Type OTHER

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

Hospital Care

Standard of care for stem cell transplant recipients where the aftercare is done in hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Clinic Care

Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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home care

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

Intervention Type OTHER

Eligibility Criteria

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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


* 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 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


None
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Sung, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Nelson Chao, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea Pires, MS

Role: CONTACT

919-613-1546

Facility Contacts

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Anthony Sung, MD

Role: primary

919-668-5710

Other Identifiers

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Pro00089697

Identifier Type: -

Identifier Source: org_study_id

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