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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to ensure patients receive timely colonoscopies if they have high-risk colon polyps. These polyps can lead to colorectal cancer, a serious disease often preventable with regular screening. The study examines two approaches: one group receives extra reminders and assistance in scheduling colonoscopies, while the other follows usual care routines. This is part of a multilevel intervention to improve colorectal cancer surveillance. Individuals diagnosed with high-risk polyps in the last five years, who have not had colorectal cancer or certain other bowel diseases, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance cancer prevention strategies.

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 prior data suggests that this multilevel intervention is safe for improving colonoscopy surveillance?

Research has shown that multilevel interventions, like the one tested in this trial, have increased colorectal cancer screening rates in other studies. These interventions engage various groups, such as clinics, doctors, and patients, to enhance healthcare processes.

Specific data on side effects or safety issues for this type of intervention is not available. However, because it primarily involves reminders and scheduling tools, it is generally considered safe. The goal is to ensure patients receive their follow-up colonoscopies on time. This approach focuses on improving healthcare organization rather than introducing a new drug or medical procedure.

In summary, the intervention emphasizes organizing and reminding, not taking new medicine or undergoing risky procedures. This approach is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance colorectal cancer surveillance through a multilevel intervention, which could lead to earlier detection and improved outcomes. Unlike standard follow-up care, this approach integrates advanced electronic health record (EHR) features, like automatic updates to medical problem lists and reminders for both providers and patients. Participants benefit from proactive scheduling calls and multiple reminders, including notifications six months in advance via their patient portal and mail, as well as follow-up calls. This comprehensive system could ensure more timely colonoscopies, potentially catching cancer earlier and improving patient care.

What evidence suggests that this trial's multilevel intervention could be effective for improving colonoscopy surveillance in patients with high risk colon polyps?

This trial will compare a multilevel intervention with standard follow-up care to improve colorectal cancer (CRC) screening rates. Research has shown that using multiple strategies can significantly increase CRC screening rates. One study found that these strategies led to a 20.29% rise in CRC screenings. These methods often include sending reminders and following up with both patients and healthcare providers to ensure timely screenings. Another study found that efforts like mailing reminders and assisting patients in navigating the process effectively increased participation. Overall, these strategies have proven effective in ensuring timely follow-up after abnormal cancer screenings, making them a promising way to lower CRC risk. ^{2 3 6 7 8}

Who Is on the Research Team?

Folasade P. May

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827032

Intervention and Outreach for Colorectal Cancer Screening The authors reported an absolute increase of 20.29 percentage points in CRC screening with the multilevel interventions, and a 24.3 percentage– ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8288035/

What Multi-Level Interventions Do We Need to Increase the ... The most effective interventions to increase screening include outreach with mailed or in-person distributed fecal blood tests; and patient navigation.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002222

Protocol for a Multilevel Intervention to Improve Screening ... This study assesses the effectiveness of two multilevel interventions to increase screening participation and follow-up after abnormal screening in under- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10565610/

A Multilevel Primary Care Intervention to Improve Follow- ... To improve the systematic follow-up of abnormal cancer screening test results, we developed a multilevel intervention and evaluated the intervention in a ...

5. cdc.gov cdc.gov/pcd/issues/2025/25_0025.htm

Interventions to Increase Colorectal Cancer Screening ... We performed a scoping review to describe the types and effectiveness of interventions to increase CRC screening in primarily rural settings.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10507149/

The use of individual and multilevel data in ... We compared the effectiveness of a CRC screening risk prediction model that uses multilevel data with a more conventional model that uses only individual ...

7. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-020-01045-4

Implementing a multilevel intervention to accelerate colorectal ... The ACCSIS-Chicago will implement a multilevel, multicomponent intervention to increase rates of CRC screening, follow-up, and referral-to-care ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3674918/

Systems intervention to promote colon cancer screening in ... This paper describes the study protocol for a trial designed to increase colorectal cancer screening in those 'safety-net' health centers that ...