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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancies
• Intervention / Treatment: Other: Home Care

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
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel Microbiota	The bowel microbiota before and during the first 100 days.	100 days

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Nelson Chao, MD, MBA, Duke University

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): September 30, 2017
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (ESTIMATE): November 12, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: stem cell transplant; home care; bowel microbiota
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: Pro00032263