A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
|ClinicalTrials.gov Identifier: NCT01725022|
Recruitment Status : Active, not recruiting
First Posted : November 12, 2012
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Other: Home Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 30, 2017|
|Estimated Study Completion Date :||June 2019|
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.
- Bowel Microbiota [ Time Frame: 100 days ]The bowel microbiota before and during the first 100 days.
- Nutritional status using the PG-SGA assessment tool [ Time Frame: 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.
- Incidence of acute Graft Versus Host Disease (GVHD) [ Time Frame: 100 days ]All incidences of Grade II-IV GVHD will be quantified.
- Treatment related morbidities and mortalities [ Time Frame: 100 Days ]Both treatment related morbidities and mortalities will be quantified.
- Quality Of Life Assessment (QOL) [ Time Frame: 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.
- Costs of care [ Time Frame: 100 Days ]The mean, median and range of costs will be compared in the three arms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725022
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Nelson Chao, MD, MBA||Duke University|