NCT04673890

Brief Summary

Significant challenges and gaps remain in navigating transitions between acute care and outpatient care for many cancer survivors. This study underscores 1) implementation of Emergency Department (ED) risk-stratified treatments protocols that standardize patient care and would allow for rapid re-assessment and access to specialist care with well-coordinated cancer care plans, and 2) the significant numbers of minority cancer survivors seeking episodic care in the ED that are at increased risk of not receiving recommended post cancer treatment surveillance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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

August 6, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

November 30, 2020

Last Update Submit

November 21, 2022

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

  • ED utilization rate

    Emergency department utilization over 6 month period

    6 months from study entry

  • Mortality

    Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality

    30 days from study entry

  • Mortality

    Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality

    90 days from study entry

  • Mortality

    Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality

    1 year from study entry

Secondary Outcomes (1)

  • Admission and Readmission rate

    6 months from study entry

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient recruitment will be completed in the UI Health ED with ED patients who have had a cancer in their lifetime.

You may qualify if:

  • Cancer survivor (has had cancer in their lifetime, and is currently disease-free)
  • Verbal fluency in English or Spanish
  • Age 18-75 years

You may not qualify if:

  • Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
  • Plans to move from Chicago area within the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

  • Singh GK, Jemal A. Socioeconomic and Racial/Ethnic Disparities in Cancer Mortality, Incidence, and Survival in the United States, 1950-2014: Over Six Decades of Changing Patterns and Widening Inequalities. J Environ Public Health. 2017;2017:2819372. doi: 10.1155/2017/2819372. Epub 2017 Mar 20.

    PMID: 28408935BACKGROUND

  • Moore JX, Akinyemiju T, Bartolucci A, Wang HE, Waterbor J, Griffin R. A prospective study of cancer survivors and risk of sepsis within the REGARDS cohort. Cancer Epidemiol. 2018 Aug;55:30-38. doi: 10.1016/j.canep.2018.05.001. Epub 2018 May 25.

    PMID: 29763753BACKGROUND

  • Connolly GC, Francis CW. Cancer-associated thrombosis. Hematology Am Soc Hematol Educ Program. 2013;2013:684-91. doi: 10.1182/asheducation-2013.1.684.

    PMID: 24319253BACKGROUND

  • Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstrom J. Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost. 2007 Apr;5(4):692-9. doi: 10.1111/j.1538-7836.2007.02450.x.

    PMID: 17367492BACKGROUND

  • Prendergast HM, Khosla S. Lessons learned about policymaking: Moving an emergency department-initiated screening protocol to systemwide input in the development and implementation process. Acad Emerg Med. 2023 Jun;30(6):683-686. doi: 10.1111/acem.14672. Epub 2023 Feb 24. No abstract available.

    PMID: 36707976DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Heather Prendergast

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 17, 2020

Study Start

August 6, 2020

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

US(1)