Improved Surveillance for Colorectal Cancer

Overseen By Jenna Alarcon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Colorectal carcinoma, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: Unknown

1680 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.

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 Multilevel Intervention for colorectal cancer?

The multilevel intervention aims to increase colorectal cancer screening and follow-up in health centers, which is crucial for early detection and prevention. Evidence shows that timely screening and follow-up can significantly reduce colorectal cancer cases and deaths, especially in vulnerable populations. ^{1 2 3 4 5}

How does the multilevel intervention treatment for colorectal cancer differ from other treatments?

The multilevel intervention for colorectal cancer is unique because it targets multiple levels of influence, including the organization, provider, and individual, to improve screening, follow-up, and referral-to-care rates. It includes components like provider and staff education, reminders, assessments, feedback, and patient navigation, making it more comprehensive than single-level interventions. ^{1 3 4 6 7}

Research Team

Folasade P. May

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with high-risk colon polyps, who are at increased risk for colorectal cancer. It aims to improve their adherence to recommended repeat colonoscopies every three years to lower their cancer risk.

Inclusion Criteria

12 patients who did and 12 patients who did not have surveillance colonoscopy

Administrators who are involved in care processes related to CRC screening, HRN surveillance, and/or colonoscopy scheduling

Primary care providers (PCPs) and gastroenterologists (GIs)

Exclusion Criteria

HRN cases not confirmed by chart review (human-in-the-loop)

I have a history of colorectal cancer, Crohn's, ulcerative colitis, or polyposis syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete an interview over 20-30 minutes and clinics implement multilevel interventions including EHR updates and patient reminders

3.5 years

Follow-up

Participants are monitored for completion of surveillance colonoscopy and cost-effectiveness of the intervention

3.5 years

Treatment Details

Interventions

• Multilevel Intervention

Trial Overview The study tests a multilevel intervention that targets clinics, healthcare providers, and patients themselves. The goal is to enhance the rate of timely follow-up colonoscopy screenings in individuals with high-risk polyps.

Participant Groups

Group I: Arm I(Multilevel intervention) Experimental Treatment 2 Interventions

Aim 1: Participants complete an interview over 20-30 minutes. Aim 2: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records (EHR). Clinics also call patients to schedule their colonoscopy. Providers receive reminders and pending orders for the colonoscopy in the electronic health record. Patients receive a reminder 6 months in advance via their patient portal and mail to schedule a colonoscopy, and also receive a phone call from the patient communication center.

Group II: Arm II (Standard follow up) Active Control 2 Interventions

Patients receive care according to the clinics' usual care practices.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

This study aims to implement a comprehensive multilevel intervention to increase colorectal cancer (CRC) screening and follow-up care in federally qualified health centers, targeting organizational, provider, and individual levels to address disparities in CRC outcomes among vulnerable populations.

The intervention includes various components such as education for providers and staff, reminders, assessments, and patient navigation, and will be evaluated through a three-phase randomized trial involving four clinic clusters over a total of 15 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a multilevel intervention to accelerate colorectal cancer screening and follow-up in federally qualified health centers using a stepped wedge design: a study protocol. Kim, K., Polite, B., Hedeker, D., et al.[2021]

A study analyzing data from 6890 colorectal cancer patients in New South Wales found significant variations in care processes across 105 hospitals, particularly affecting older adults who were less likely to receive timely treatment and multidisciplinary discussions.

Patient characteristics, such as age, disease extent, and comorbidity scores, were strongly linked to poorer outcomes, suggesting that these factors should be considered when comparing hospital performance and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of variation in colorectal cancer care and outcomes in New South Wales: a population-based health data linkage study. Jorgensen, ML., Young, JM., Dobbins, TA., et al.[2019]

In a study of colorectal cancer surveillance decisions, nurse coordinator-led models in public academic hospitals showed a high compliance rate of 97% with evidence-based guidelines, compared to 83% compliance in physician-led models in private non-academic hospitals.

The findings suggest that the nurse-led model not only adheres better to guidelines but may also help optimize colonoscopy resources, as fewer unnecessary procedures were performed ahead of schedule.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-led model at public academic hospitals maintains high adherence to colorectal cancer surveillance guidelines. Symonds, EL., Simpson, K., Coats, M., et al.[2020]

Timely colorectal cancer (CRC) screening is proven to significantly reduce CRC morbidity and mortality, yet only about two-thirds of the US population is up to date with recommended screenings, with even lower rates among vulnerable groups.

To effectively address these disparities, there is a need for a stronger evidence base that identifies the multilevel factors affecting screening and develops targeted interventions, utilizing systems science to optimize implementation strategies across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Powered Participatory Decision Making: Leveraging Systems Thinking and Simulation to Guide Selection and Implementation of Evidence-Based Colorectal Cancer Screening Interventions. Wheeler, SB., Leeman, J., Hassmiller Lich, K., et al.[2021]

In a study of 314 Medicare beneficiaries with colorectal cancer, 76.1% adhered to office visit guidelines, but only 36.9% and 48.1% adhered to CEA testing and colonoscopy guidelines, respectively, indicating a significant gap in follow-up care.

Positive ratings of personal and specialist doctors were linked to better adherence to office visits, suggesting that strong patient-provider relationships may enhance compliance with surveillance guidelines, which is crucial for improving survival rates among colorectal cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining colorectal cancer survivors' surveillance patterns and experiences of care: a SEER-CAHPS study. Mollica, MA., Enewold, LR., Lines, LM., et al.[2018]

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]

Multilevel interventions, which target various levels from individual to community, are believed to be more effective for cancer prevention and treatment than single-level interventions, but evidence supporting their superiority is still limited.

Research designs that assess the impact of these multilevel interventions on patient outcomes are rare, highlighting the need for studies that clarify how different levels of intervention contribute to health improvements in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel interventions: study design and analysis issues. Cleary, PD., Gross, CP., Zaslavsky, AM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementing a multilevel intervention to accelerate colorectal cancer screening and follow-up in federally qualified health centers using a stepped wedge design: a study protocol. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Predictors of variation in colorectal cancer care and outcomes in New South Wales: a population-based health data linkage study. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

A nurse-led model at public academic hospitals maintains high adherence to colorectal cancer surveillance guidelines. [2020]

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

Data-Powered Participatory Decision Making: Leveraging Systems Thinking and Simulation to Guide Selection and Implementation of Evidence-Based Colorectal Cancer Screening Interventions. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Examining colorectal cancer survivors' surveillance patterns and experiences of care: a SEER-CAHPS study. [2018]

6. 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]

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

Multilevel interventions: study design and analysis issues. [2021]