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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.
Subjects enrolled in the medical home arm and those serving as concurrent controls will have the following studies:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Care | Experimental | This is the arm for patients who receive their transplant care in their homes. |
|
| Hospital Care | No Intervention | Standard of care for stem cell transplant recipients where the aftercare is done in hospital. | |
| Clinic Care | No Intervention | Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Care | Other | This is the interventional arm where patients receive the transplant care in their homes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Microbiota | The bowel microbiota before and during the first 100 days. | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of acute Graft Versus Host Disease (GVHD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Chao, MD, MBA | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D006699 | Home Care Services |
| ID | Term |
|---|---|
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009739 | Nursing Services |
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All incidences of Grade II-IV GVHD will be quantified. |
| 100 days |
| Treatment related morbidities and mortalities | Both treatment related morbidities and mortalities will be quantified. | 100 Days |
| 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 |
| Costs of care | The mean, median and range of costs will be compared in the three arms. | 100 Days |