Screening Tools for Colorectal Cancer

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Colorectal cancer, Non-English/Spanish, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

9865 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Algorithmic Risk Stratification Tool, Computerized Risk Stratification Tool, Step completion assessment for colorectal cancer?

The study on predicting 90-day mortality after colorectal cancer surgery suggests that personalized risk assessment tools can help tailor treatment and improve outcomes, which supports the potential effectiveness of using risk stratification tools in colorectal cancer care. ^{1 2 3 4 5}

Is the Algorithmic Risk Stratification Tool safe for humans?

The research articles do not provide specific safety data for the Algorithmic Risk Stratification Tool or similar tools in humans. ^{6 7 8 9 10}

How does the colorectal cancer screening tool differ from other treatments?

This treatment is unique because it uses the National Cancer Institute's Colorectal Cancer Risk Assessment Tool to personalize screening based on individual risk, potentially improving screening efficiency and participation compared to standard one-size-fits-all approaches. ^{6 9 11 12 13}

What is the purpose of this trial?

The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Center is to optimize colon cancer screening through personalized regimens in the integrated safety-net clinical provider network, which serves a large and diverse population of under- and un-insured patients in Dallas. Together, three research projects will assess clinic, system, and organizational factors associated with over-, under- and guideline-based screening among this important population and will compare benefits, harms, and costs of strategies for facilitating optimized screening regimens. The theme of optimizing colorectal cancer screening in a safety-net clinical provider network brings together several components. Its focus on colorectal cancer (CRC) screening which is important, because CRC is the second cancer killer in the US while being the only major cancer for which optimized screening results in primary prevention. Despite this strong potential benefit, CRC screening remains suboptimal overall, and especially among low-income and minority individuals served by safety-nets. Safety-net networks therefore offer tremendous potential for CRC prevention and control, but numerous factors at the clinics-, system-, and organization-level influence their ability to provide optimized care.

Research Team

Celette Skinner, PhD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for men and women aged 25-64 who are visiting the clinic. Those aged 25-49 must have a family history of colorectal cancer or their own history of bowel disease or polyps. All racial and ethnic groups, as well as English and Spanish speakers, can join. People with personal colorectal cancer history, severe hearing/speech impairments, or without informed consent cannot participate.

Inclusion Criteria

I am between 25 and 64 years old.

No racial or ethnic group will be excluded from participation

I am aged 25-49 and have a family history of colon cancer or a personal history of bowel inflammation or polyps.

Exclusion Criteria

I have never had colorectal cancer.

I speak English or Spanish and can hear, speak, and have given my consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Personalized Screening Assessment

Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening

3 years

Follow-up

Participants are monitored for completion of guideline-based screening processes and follow-up of abnormal test results

3 years

Treatment Details

Interventions

• Algorithmic Risk Stratification Tool
• Computerized Risk Stratification Tool
• Step completion assessment

Trial Overview The PROSPR project aims to find the best ways to screen for colon cancer in a diverse group using safety-net clinics. It will test tools like step completion assessments and computerized risk stratification algorithms to personalize screening methods based on individual risks.

Participant Groups

Group I: Screening Experimental Treatment 3 Interventions

Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening. Interventions include Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, and Step completion assessment.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

Patients in surgical oncology express a strong need for better educational resources, indicating a gap in perioperative information.

Both patients and providers support the use of a mobile application to enhance patient education, although providers initially see patient onboarding as a potential burden; however, they believe it could ultimately streamline workflows and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider perceptions on utilizing a mobile technology platform to improve surgical outcomes in the perioperative setting. Huynh, B., Barrett, J., Joachim, A., et al.[2021]

A personalized outcome prediction tool for knee arthroplasty patients was developed, demonstrating good accuracy in predicting length of stay (LOS) and 90-day readmission rates, with accuracies of 71.5% and 65.0% respectively.

The tool also effectively predicted one-year improvements in patient-reported outcomes, achieving high accuracy rates of around 72% for pain, function, and quality of life scores, based on data from over 8,000 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a personalized outcome prediction tool for knee arthroplasty. Anis, HK., Strnad, GJ., Klika, AK., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient and provider perceptions on utilizing a mobile technology platform to improve surgical outcomes in the perioperative setting. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Quality assessment of colorectal cancer care: an international online model. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Prediction of 90-day mortality after surgery for colorectal cancer using standardized nationwide quality-assurance data. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Novel Preoperative Patient Survey Predicts Adverse Patient Outcomes-Implementation and Preliminary Results of the Tennessee Preoperative Assessment Tool. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Developing a personalized outcome prediction tool for knee arthroplasty. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Targeted screening for colorectal cancer in high-risk individuals. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Natural Language Processing of Clinical Notes With a Validated Risk-Stratification Tool to Predict Severe Maternal Morbidity. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Risk Stratification Index 3.0, a Broad Set of Models for Predicting Adverse Events during and after Hospital Admission. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Personalized Colorectal Cancer Risk Assessment vs Education to Promote Screening Uptake. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Assessing the value of risk predictions by using risk stratification tables. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Advanced neoplasia in Veterans at screening colonoscopy using the National Cancer Institute Risk Assessment Tool. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Increasing preventive health services via tailored health communications. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Predicting advanced neoplasia at colonoscopy in a diverse population with the National Cancer Institute colorectal cancer risk-assessment tool. [2018]