Major Complication Rate in Cancer Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program

August 27, 2025 updated by: M.D. Anderson Cancer Center

A Descriptive Study of Major Complications in Oncology Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program

This study investigates the major complication rate in cancer patients potentially eligible for a hospital at home program for management of neutropenic fever. "Hospital at Home" is a home care program that provides acute, inpatient care in a patient's home in place of a traditional hospital stay. Learning more about the characteristics of potentially eligible patients, including reasons for inpatient admission, rates of major complications, and situations or treatments that would be difficult to deliver in an at home setting may help to inform future program development.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Estimate the major complication rate among patients potentially eligible for a hospital at home program for management of neutropenic fever.

SECONDARY OBJECTIVES:

I. Describe the demographic and clinical characteristics of patients potentially eligible for admission to a hospital at home program for management of neutropenic fever.

II. Describe situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home program (e.g., blood transfusions, echocardiograms, computed tomography [CT] scans).

OUTLINE:

Patients' medical charts are reviewed.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Tacara N. Soones

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019

Description

Inclusion Criteria:

  • Admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019
  • Be at low risk for major complications as defined by a Multinational Association for Supportive Care in Cancer (MASCC) score < 21

Exclusion Criteria:

  • Reside in a nursing home
  • Homelessness
  • Hospice enrollment
  • A secondary reason for admission to the hospital or high risk clinical feature not captured in the MASCC score that places them at high risk for major complications in a hospital at home program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (chart review)
Patients' medical charts are reviewed.
Other: Medical Chart Review
Review of medical charts
Other Names:
  • Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who experience major complications that require escalated care
Time Frame: 1 month
Percentages will be presented with exact binomial 95% confidence interval. Also, will identify significant predictors of major complications (yes or no) using univariable logistic regression.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient demographic, clinical, and psychosocial features
Time Frame: 1 month
Will describe the study sample demographic, clinical, and psychosocial features. Descriptors will include frequencies, percentages, means with standard deviations, or medians with interquartile ranges, and minimum and maximum values as appropriate.
1 month
Situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home (HaH) program
Time Frame: 1 month
Will enumerate situations and treatments observed in the study sample that could not be handled optimally in the HaH environment.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Tacara N Soones, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Actual)

November 18, 2024

Study Completion (Actual)

November 18, 2024

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0394 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-06606 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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