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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01725022
First received: November 8, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention
Hematologic Malignancies
Other: Home Care

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Bowel Microbiota [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    The bowel microbiota before and during the first 100 days.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 90
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)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725022

Contacts
Contact: Krista Rowe, MSN, AOCNS (919) 684-7115 krista.rowe@duke.edu
Contact: Martha Lassiter, MSN OCN (919) 668-6239 martha.lassiter@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Krista Rowe, MSN, AOCNS    919-684-7115    krista.rowe@duke.edu   
Contact: Carolyn McDonald, RN, ONS    919-613-5042    mcdon011@mc.duke.edu   
Principal Investigator: Nelson Chao, MD, MBA         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Nelson Chao, MD, MBA Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01725022     History of Changes
Other Study ID Numbers: Pro00032263
Study First Received: November 8, 2012
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014