NCT01725022

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Home Care	This is the interventional arm where patients receive the transplant care in their homes.

Timeline

• Start date: 2012-02-01
• Primary completion: 2017-09-30
• Completion: 2017-09-30
• First posted: 2012-11-12
• Last updated: 2019-07-16

Locations

1 site across 1 country: United States