Cancer Screening Methods for Colorectal and Liver Cancer

(GTI Trial)

Overseen By Shari S Rogal, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Under 18, Not in VA, Hospice

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to encourage more people to get screened for colon and liver cancer. It compares two methods: direct outreach to patients (Patient Navigation) and assisting healthcare providers in resolving testing issues (Implementation Facilitation). The trial will monitor the number of people tested over time and collect feedback from participants. Veterans using VA healthcare, with a history of liver cirrhosis or a positive stool test for colorectal cancer screening, may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to enhancing cancer screening methods for veterans.

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 these cancer screening methods are safe?

Studies have shown that patient navigation and implementation facilitation effectively increase cancer screening rates. Patient navigation helps individuals overcome obstacles to screening, and research indicates it can boost participation without causing harm or discomfort.

Implementation facilitation assists healthcare providers in enhancing their processes to offer screenings. This method has been successfully applied in various healthcare settings, consistently increasing screening rates safely for both staff and patients.

Overall, both methods aim to make cancer screening more accessible and straightforward, focusing on support without introducing risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to improve cancer screening for colorectal and liver cancer. Unlike standard screening methods that rely heavily on patients navigating complex healthcare systems on their own, this trial focuses on two innovative approaches: Patient Navigation (PN) and Implementation Facilitation (IF). PN involves dedicated navigators who guide patients through the healthcare process, potentially increasing screening rates by removing barriers. IF, on the other hand, aims to enhance healthcare providers' efficiency and effectiveness by utilizing facilitators to improve implementation of screening protocols. These methods could lead to earlier detection and better outcomes for patients, making the trial a promising step forward in cancer care.

What evidence suggests that this trial's methods could be effective for increasing cancer screening rates?

This trial will compare two methods for improving cancer screening rates: Patient Navigation and Implementation Facilitation. Studies have shown that Patient Navigation, which involves guiding patients through the healthcare process, can increase colorectal cancer screening rates by 7.3 percentage points compared to usual care. This approach supports individuals in obtaining necessary tests by providing direct assistance and information. Meanwhile, Implementation Facilitation aids healthcare providers in enhancing their procedures and systems, effectively increasing screening rates. Both methods, tested in separate arms of this trial, have proven to raise the number of people getting tested for colorectal and liver cancers, potentially leading to earlier detection of these cancers. ^{1 5 6 7 8}

Who Is on the Research Team?

Shari S Rogal, MD, MPH

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for veterans who may be at risk of gastrointestinal cancers, such as colon or liver cancer. It's designed to find better ways to increase cancer screening rates among this group.

Inclusion Criteria

I am a veteran over 45 with a positive stool test in the last 18 months.

Providers: Healthcare provider or related staff at participating VA site or engaged in CRC or HCC screening pathways in an included VA site (e.g., scheduling)

Veterans: Enrolled in Veterans Health Administration (VA)

Exclusion Criteria

Veterans: Limited life expectancy (< 6 months), defined as having a code for hospice

Veterans: Not enrolled in VA

Veterans: No VA encounters in the prior 18 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of Patient Navigation (PN) and Implementation Facilitation (IF) strategies to improve cancer screening rates

12 months

Ongoing site visits and virtual check-ins

Follow-up

Participants are monitored for the maintenance of cancer screening practices and outcomes

12 months post-intervention

Maintenance

Assessment of the sustainment of HCC and CRC screening practices

6-12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Facilitation
• Patient Navigation

Trial Overview

The study compares two methods to boost cancer screenings: direct outreach to patients and support for providers to overcome barriers in the testing process. The effectiveness will be measured by changes in screening rates.

How Is the Trial Designed?

Group I: Patient Navigation (PN) Active Control 1 Intervention

Half of the HCC sites and half of the CRC sites will be randomized to PN delivered by Clinical Resource Hub navigators.

Group II: Implementation Facilitation (IF) Active Control 1 Intervention

Half of the HCC sites and half of the CRC sites will be randomized to IF delivered by 2 facilitators (one clinical and one evaluation expert) per site.

Implementation Facilitation is already approved in United States for the following indications:

Approved in United States as Implementation Facilitation for:

• Improving pain care pathways
• Enhancing non-pharmacological pain treatments
• Reducing risky substance use

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Patient navigation interventions have shown some efficacy in increasing cancer screening participation by 10.8% to 17.1% and improving adherence to diagnostic follow-up care by 21% to 29.2% compared to control patients, based on a review of 16 studies.

However, there is limited evidence on the effectiveness of patient navigation in reducing late-stage cancer diagnoses or improving treatment initiation and survivorship outcomes, indicating a need for further research to assess their overall impact and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation: state of the art or is it science? Wells, KJ., Battaglia, TA., Dudley, DJ., et al.[2022]

Colorectal cancer screening significantly reduces mortality, yet adherence rates are low, falling short of the National Colorectal Cancer Roundtable's goal of 80%.

Various interventions, such as outreach programs, navigation assistance, patient and provider education, reminders, and financial incentives, have been shown to effectively increase screening uptake, with offering a choice of screening strategies leading to higher adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Multilevel Interventions Do We Need to Increase the Colorectal Cancer Screening Rate to 80%? Inadomi, JM., Issaka, RB., Green, BB.[2022]

The study characterized 8 patient navigation programs under the National Cancer Institute's ACCSIS initiative, highlighting their diverse socio-ecological contexts and implementation strategies for colorectal cancer screening and follow-up.

Most programs adapted existing evidence-based navigation methods, with some starting navigation at the initial screening stage and others at follow-up, indicating flexibility in addressing patient needs and enhancing participation in colorectal cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. Coronado, GD., Ferrari, RM., Barnes, A., et al.[2023]

Colorectal cancer screening is crucial for reducing mortality, yet only 58.6% of adults are up-to-date with screenings, highlighting a significant gap in preventive care.

Implementing patient navigation interventions can effectively increase adherence to colorectal cancer screening and help reduce health disparities, but requires careful design considering factors like community characteristics, navigator qualifications, and evaluation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key considerations in designing a patient navigation program for colorectal cancer screening. DeGroff, A., Coa, K., Morrissey, KG., et al.[2021]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

Patient navigation significantly enhances patients' involvement in their cancer treatment, particularly by addressing emotional and informational needs, as highlighted in interviews with 28 cancer patients.

The study emphasizes the importance of a strong partnership between patients and navigators, suggesting that emotional support and effective communication are more critical than logistical assistance in the navigation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. Rousseau, SJ., Humiston, SG., Yosha, A., et al.[2021]

Citations

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A mailed FIT outreach and patient navigation program led to a significant 7.3–percentage point increase in colorectal cancer (CRC) screening over usual care.

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Implementation strategies for enhancing colorectal cancer screening were effective. •. Centers increased their use of evidence-based interventions for screening ...