Back to resultsA Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Primary Purpose
Hematologic Malignancies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Care
Sponsored by
About this trial
This is an interventional health services research trial for Hematologic Malignancies focused on measuring stem cell transplant, bowel microbiota, home care
Eligibility Criteria
Inclusion Criteria:
- 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
- Age 18-80 years of age
- Karnofsky Performance Scale (KPS) > 80
- 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:
- Lack of a caregiver
- 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.)
- Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Home Care
Hospital Care
Clinic Care
Arm Description
This is the arm for patients who receive their transplant care in their homes.
Standard of care for stem cell transplant recipients where the aftercare is done in hospital.
Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.
Outcomes
Primary Outcome Measures
Bowel Microbiota
The bowel microbiota before and during the first 100 days.
Secondary Outcome Measures
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.
Incidence of acute Graft Versus Host Disease (GVHD)
All incidences of Grade II-IV GVHD will be quantified.
Treatment related morbidities and mortalities
Both treatment related morbidities and mortalities will be quantified.
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.
Costs of care
The mean, median and range of costs will be compared in the three arms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01725022
Brief Title
A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Official Title
A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly for the first four weeks, at day 60 and 100.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
stem cell transplant, bowel microbiota, home care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Care
Arm Type
Experimental
Arm Description
This is the arm for patients who receive their transplant care in their homes.
Arm Title
Hospital Care
Arm Type
No Intervention
Arm Description
Standard of care for stem cell transplant recipients where the aftercare is done in hospital.
Arm Title
Clinic Care
Arm Type
No Intervention
Arm Description
Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.
Intervention Type
Other
Intervention Name(s)
Home Care
Intervention Description
This is the interventional arm where patients receive the transplant care in their homes.
Primary Outcome Measure Information:
Title
Bowel Microbiota
Description
The bowel microbiota before and during the first 100 days.
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Nutritional status using the PG-SGA assessment tool
Description
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.
Time Frame
100 days
Title
Incidence of acute Graft Versus Host Disease (GVHD)
Description
All incidences of Grade II-IV GVHD will be quantified.
Time Frame
100 days
Title
Treatment related morbidities and mortalities
Description
Both treatment related morbidities and mortalities will be quantified.
Time Frame
100 Days
Title
Quality Of Life Assessment (QOL)
Description
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.
Time Frame
100 Days
Title
Costs of care
Description
The mean, median and range of costs will be compared in the three arms.
Time Frame
100 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Age 18-80 years of age
Karnofsky Performance Scale (KPS) > 80
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:
Lack of a caregiver
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.)
Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Chao, MD, MBA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
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