Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT01725022
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Subjects enrolled in the medical home arm and those serving as concurrent controls will have the following studies:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is the interventional arm where patients receive the transplant care in their homes.
Time frame: 100 days
The bowel microbiota before and during the first 100 days.
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.
Time frame: 100 days
All incidences of Grade II-IV GVHD will be quantified.
Time frame: 100 Days
Both treatment related morbidities and mortalities will be quantified.
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.
Time frame: 100 Days
The mean, median and range of costs will be compared in the three arms.
Duke University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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