A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care|
- Bowel Microbiota [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]The bowel microbiota before and during the first 100 days.
- Nutritional status using the PG-SGA assessment tool [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]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) [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]All incidences of Grade II-IV GVHD will be quantified.
- Treatment related morbidities and mortalities [ Time Frame: 100 Days ] [ Designated as safety issue: Yes ]Both treatment related morbidities and mortalities will be quantified.
- Quality Of Life Assessment (QOL) [ Time Frame: 100 Days ] [ Designated as safety issue: No ]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 [ Time Frame: 100 Days ] [ Designated as safety issue: No ]The mean, median and range of costs will be compared in the three arms.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Home Care
This is the arm for patients who receive their transplant care in their homes.
Other: Home Care
This is the interventional arm where patients receive the transplant care in their homes.
No Intervention: Hospital Care
Standard of care for stem cell transplant recipients where the aftercare is done in hospital.
No Intervention: Clinic Care
Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725022
|Contact: Krista Rowe, MSN, AOCNS||(919) email@example.com|
|Contact: Martha Lassiter, MSN OCN||(919) firstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Krista Rowe, MSN, AOCNS 919-684-7115 email@example.com|
|Contact: Carolyn McDonald, RN, ONS 919-613-5042 firstname.lastname@example.org|
|Principal Investigator: Nelson Chao, MD, MBA|
|Principal Investigator:||Nelson Chao, MD, MBA||Duke University|