A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care

NCT ID: NCT01725022

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-09-30

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.

Detailed Description

Subjects enrolled in the medical home arm and those serving as concurrent controls will have the following studies:

1. Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly for the first four weeks, at day 60 and 100.

2. The PG-SGA, FACT-BMT and other patient-reported symptom instruments will be collected weekly for the first 4 weeks, at day 60, 100 and patients will be required to complete a daily food diary.

3. Other assessments for toxicities or GVHD will proceed as per current standard of care, for a total blood draw amount of 100 mls from home care subjects and concurrent controls.

Conditions

Hematologic Malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Home Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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

2. Age 18-80 years of age

3. Karnofsky Performance Scale (KPS) > 80

4. 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)

Exclusion Criteria

1. Lack of a caregiver

2. 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.)

3. Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelson Chao, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00032263

Identifier Type: -

Identifier Source: org_study_id