Colorectal Cancer Screening Intervention for Colorectal Cancer

(RISCC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Inflammatory bowel disease, previous colorectal cancer, others

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

Compensation: Varies

Number of Visits: Unknown

11 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this implementation study is to support an evidence-based intervention to the improve colorectal cancer (CRC) screening and diagnostic colonoscopy rates in rural Indiana. The main questions the study aims to answer are: * How does the implementation of an evidence based intervention to increase CRC screening in rural Indiana improve CRC screening and diagnostic colonoscopy rates, defined as completed screening episode? * Will dose and type of implementation strategies contribute to differences in contextual factors and readiness as well as different levels of implementation outcomes (reach and implementation) in rural clinic? * Will Contextual factors (innovation, recipient, inner and outer context) and implementation outcomes (reach, and implementation) vary with the levels of CRC screening and diagnostic colonoscopy following active implementation (effectiveness) and throughout maintenance compared to baseline (usual care)? * What is the cost and budget impact of the deployment of implementation strategies and processes for rural clinics and evaluate the cost-effectiveness of implementing and sustaining the CRC screening intervention? Approach: Participating clinics tasks consist of mailing FIT kits, sending text messages, phone reminders, and the use of a Patient Navigator to initiate a screening episode with eligible patients who are 45-75 (and have no colonoscopy in the last 10 years or FIT in the last 12 months) as identified from medical records.

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 Colorectal Screen rates with implementation of evidence-based intervention for colorectal cancer?

Research shows that systematic reminders to patients and doctors, as well as tailored interventions like web-based tools and phone counseling, can increase colorectal cancer screening rates, which helps reduce cancer incidence and deaths. ^{1 2 3 4 5}

How does this colorectal cancer screening intervention differ from other treatments?

This colorectal cancer screening intervention is unique because it focuses on increasing screening rates through strategies like mailed outreach, patient navigation, and reminders, which are particularly effective in low-income populations. Unlike traditional treatments that focus on the disease itself, this intervention aims to prevent colorectal cancer by ensuring more people get screened early. ^{1 2 3 6 7}

Research Team

Victoria Champion, PhD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for staff at certain clinics and patients aged 45-75 in rural Indiana who haven't had a colonoscopy in the past 10 years or a FIT test in the last year. It's not for those with inherited syndromes, inflammatory bowel disease, previous polyps, or colorectal cancer.

Inclusion Criteria

I am between 45 and 75 years old.

Only employees working at the clinics can participate.

I am either male or female.

Exclusion Criteria

I have a history of inflammatory bowel disease.

I have had a type of polyp called adenomatous before.

I have had colorectal cancer in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Planning and Usual Care

Usual care and planning period to establish baseline CRC screening rates and prepare for implementation

12 months

Implementation

Active implementation of the evidence-based intervention to improve CRC screening rates, including distribution of FIT kits and patient navigation

12 months

Maintenance

Monitoring continued adoption of the EBI and subsequent CRC screening, including annual repeat FIT screening and diagnostic colonoscopy

12 months

Follow-up

Participants are monitored for effectiveness and maintenance of CRC screening intervention

4 weeks

Treatment Details

Interventions

• Colorectal Screen rates with implementation of evidence-based intervention

Trial Overview The study tests if mailing FIT kits, text reminders, phone calls, and using a Patient Navigator can increase colorectal cancer screening rates. It looks at how these methods work over time compared to usual care without these efforts.

Participant Groups

Group I: Phase 3 Experimental Treatment 1 Intervention

Maintenance period.

Group II: Phase 2 Experimental Treatment 1 Intervention

Implementation period. Clinics are randomized into clusters

Group III: Phase 1 Active Control 1 Intervention

Usual care and planning period.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Indiana University Melvin and Bren Simon Cancer Center

Collaborator

Trials

7

Recruited

700+

Findings from Research

Mailed reminders to patients significantly increased colorectal cancer screening rates from 38.1% to 44.0%, especially among older age groups, indicating that targeted communication can effectively promote screening.

While electronic reminders for physicians did not show a significant overall increase in screening rates, they appeared to be beneficial for patients with frequent primary care visits, suggesting that tailored approaches may enhance screening efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Sequist, TD., Zaslavsky, AM., Marshall, R., et al.[2022]

A controlled trial involving 443 participants tested a combined intervention of a patient decision aid and practice-level support to increase colorectal cancer (CRC) screening rates, showing a modest increase in screening from 32.2% in usual care to 39% in the intervention group.

The intervention was particularly more effective for participants with higher incomes, suggesting that socioeconomic factors may influence the success of CRC screening interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Pignone, M., Winquist, A., Schild, LA., et al.[2021]

The implementation of organized colorectal cancer (CRC) screening significantly increased screening participation from 38.9% in 2000 to 82.7% in 2015, demonstrating effective outreach in a community-based population.

This increase in screening was associated with a 25.5% reduction in CRC incidence and a 52.4% reduction in cancer mortality, highlighting the program's effectiveness in early detection and prevention of advanced-stage cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population. Levin, TR., Corley, DA., Jensen, CD., et al.[2022]

Mailed outreach strategies, especially those including fecal immunohistochemical tests (FIT) or guaiac-based fecal occult blood tests (gFOBT), significantly increased colorectal cancer screening adherence in low-income populations, with relative risks of 2.20 and 4.34 respectively.

Patient navigation and non-individualized education also effectively improved screening rates, while individualized education and mailed outreach with incentives did not show significant benefits, highlighting the importance of intervention design in promoting screening adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to increase colorectal cancer screening adherence in low-income settings within the United States: A systematic review and meta-analysis. Rubin, L., Okitondo, C., Haines, L., et al.[2023]

References

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

Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. [2022]

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

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. [2021]

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

Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population. [2022]

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

A Randomized Trial to Compare a Tailored Web-Based Intervention and Tailored Phone Counseling to Usual Care for Increasing Colorectal Cancer Screening. [2021]

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

Text Messaging and Opt-out Mailed Outreach in Colorectal Cancer Screening: a Randomized Clinical Trial. [2022]

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

Adoption and Implementation of Evidence-Based Colorectal Cancer Screening Interventions Among Cancer Control Program Grantees, 2009-2015. [2022]

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

Interventions to increase colorectal cancer screening adherence in low-income settings within the United States: A systematic review and meta-analysis. [2023]