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CancerICARENCT04673890

Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care

An observational study of Cancer, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer
How many people
152 participants
Where
1 siteUnited States
Study dates
6 Aug 2020to 15 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care (ICARE)

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.

Read the detailed description

The over-arching goal of this study is to develop a portable model for ED cancer treatment guidelines and management using evidence based protocols in a population at high risk for poor cancer -related outcomes by identifying \& overcoming specific barriers to enhanced survivorship. Based on the demographics of ED population (currently, 70% racial/ethnic minorities), the majority of participants will be underrepresented (African-American and Hispanic) and low-income individuals. The investigators propose a feasibility study of 150 patients in the ED over a 1 year period.

The specific aims are:

Aim 1: Evaluate the effectiveness of ED Risk-Stratified, Evidence-Based Treatment protocols on the primary outcome of ED utilization rates and subsequent acute inpatient admissions at 6 -months post-intervention.

Aim 2: Evaluate the effectiveness of an ED-based Cancer Patient Navigator on the secondary outcomes of patient engagement and primary care engagement at 6 -months post-intervention.

Aim 3: Examine barriers and facilitators to compliance for cancer survivorship recommendations that occur in an ED setting at 6-months post intervention.

Conditions
Cancer
Medical subject headings
Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ED utilization rate

    Emergency department utilization over 6 month period

    Measured: 6 months from study entry

  2. Mortality

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

    Measured: 30 days from study entry

  3. Mortality

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

    Measured: 90 days from study entry

  4. Mortality

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

    Measured: 1 year from study entry

Secondary outcomes (1)

  1. Admission and Readmission rate

    all cause, and related to sepsis

    Measured: 6 months from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start6 Aug 2020
  3. Primary completion15 Jan 2022
  4. Study completion15 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673890
Sponsor's protocol ID
2020-0170
Other IDs
6U48DP006392
Acronym
ICARE
Status last verified
Nov 2022
First submitted
30 Nov 2020
Last updated
22 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28408935

  • 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.

    PubMed 29763753

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

    PubMed 24319253

  • 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.

    PubMed 17367492

  • 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.

    PubMed 36707976

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ED utilization rate (time frame: 6 months from study entry). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673890, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

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