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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725022
• Other study ID #: Pro00032263
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: September 30, 2017

Study information

• Verified date: July 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancies

Intervention

Other:
• Home Care
This is the interventional arm where patients receive the transplant care in their homes.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel Microbiota	The bowel microbiota before and during the first 100 days.	100 days
Secondary	Nutritional status using the PG-SGA assessment tool	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.	100 days
Secondary	Incidence of acute Graft Versus Host Disease (GVHD)	All incidences of Grade II-IV GVHD will be quantified.	100 days
Secondary	Treatment related morbidities and mortalities	Both treatment related morbidities and mortalities will be quantified.	100 Days
Secondary	Quality Of Life Assessment (QOL)	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.	100 Days
Secondary	Costs of care	The mean, median and range of costs will be compared in the three arms.	100 Days