NCT04557709

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

4.4 years

First QC Date

September 15, 2020

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who experience major complications that require escalated care

    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 Outcomes (2)

  • Patient demographic, clinical, and psychosocial features

    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

    1 month

Study Arms (1)

Observational (chart review)

Patients' medical charts are reviewed.

Other: Medical Chart Review

Interventions

Review of medical charts

Also known as: Chart Review
Observational (chart review)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Tacara N Soones

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 22, 2020

Study Start

July 13, 2020

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

September 4, 2025

Record last verified: 2025-08