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

Not Applicable

Completed

• Conditions: Hematologic Malignancies
• Interventions: Other: Home Care

• Registration Number: NCT01725022
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-12
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Care	Home Care	This is the arm for patients who receive their transplant care in their homes.

Primary Outcome Measures

Name	Time	Method
Bowel Microbiota	100 days	The bowel microbiota before and during the first 100 days.

Secondary Outcome Measures

Name	Time	Method
Incidence of acute Graft Versus Host Disease (GVHD)	100 days	All incidences of Grade II-IV GVHD will be quantified.
Treatment related morbidities and mortalities	100 Days	Both treatment related morbidities and mortalities will be quantified.
Costs of care	100 Days	The mean, median and range of costs will be compared in the three arms.
Nutritional status using the PG-SGA assessment tool	100 days	The assessment tool to capture overall nutritional status will be the Patient Generated Subjective Global Assessment (PG-SGA) which has been validated in other cancer patients.
Quality Of Life Assessment (QOL)	100 Days	The QOL assessment will utilize the FACT-BMT (Functional Assessment of Cancer Therapy Bone Marrow Transplant) assessment tool as well as other patient-reported symptom instruments to capture the patient reported experience.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States