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Completed

NCT Number: NCT01725022

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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

  • Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly for the first four weeks, at day 60 and 100.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age 18-80 years of age
  • Karnofsky Performance Scale (KPS) > 80
  • 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

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

Treatment and study plan

Home care

Other

This is the interventional arm where patients receive the transplant care in their homes.

Primary outcomes

  1. Bowel Microbiota

    Time frame: 100 days

    The bowel microbiota before and during the first 100 days.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 12, 2012
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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