A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01725022
Recruitment Status : Active, not recruiting
First Posted : November 12, 2012
Last Update Posted : June 5, 2018
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Other: Home Care Not Applicable

Detailed Description:

Subjects enrolled in the medical home arm and those serving as concurrent controls will have the following studies:

  1. Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly for the first four weeks, at day 60 and 100.
  2. 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.
  3. 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
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Bowel Microbiota [ Time Frame: 100 days ]
    The bowel microbiota before and during the first 100 days.

Secondary Outcome Measures :
  1. 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.

  2. Incidence of acute Graft Versus Host Disease (GVHD) [ Time Frame: 100 days ]
    All incidences of Grade II-IV GVHD will be quantified.

  3. Treatment related morbidities and mortalities [ Time Frame: 100 Days ]
    Both treatment related morbidities and mortalities will be quantified.

  4. 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.

  5. Costs of care [ Time Frame: 100 Days ]
    The mean, median and range of costs will be compared in the three arms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. Age 18-80 years of age
  3. Karnofsky Performance Scale (KPS) > 80
  4. 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:

  1. Lack of a caregiver
  2. 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.)
  3. Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01725022

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Nelson Chao, MD, MBA Duke University

Responsible Party: Duke University Identifier: NCT01725022     History of Changes
Other Study ID Numbers: Pro00032263
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: November 2017

Keywords provided by Duke University:
stem cell transplant
bowel microbiota
home care