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

30300 Participants Needed

Trial Summary

What is the purpose of this trial?

Gastrointestinal cancers such as colon cancer and liver cancer cause many deaths in the US. Testing could catch these cancers early, helping people live longer. The goal of this study is to compare two different ways of getting more people tested for these cancers: 1) by directly reaching out to the people who need testing or 2) by helping providers fix issues that hold up testing. The main question it aims to answer is: how should healthcare systems go about choosing one or the other? Researchers will look at cancer testing rates over time at sites that are trying these different approaches. They will also survey and interview participants from these sites.

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 Implementation Facilitation, Implementation Facilitation Strategy, Facilitated Implementation, Patient Navigation, Patient Navigation Services, Care Coordination, Healthcare Navigation for cancer screening?

Patient navigation has shown promise in increasing participation in colorectal cancer screening and follow-up, with reported increases in screening participation ranging from 10.8% to 17.1% and adherence to diagnostic follow-up care from 21% to 29.2% compared to control patients. ^{1 2 3 4 5}

Is patient navigation safe for humans?

Patient navigation programs, which help guide patients through cancer screening and treatment, have been implemented in various settings and are generally considered safe. They focus on improving access to care and supporting patients, without introducing direct medical risks. ^{1 2 6 7 8}

How does the treatment Implementation Facilitation and Patient Navigation differ from other treatments for colorectal and liver cancer?

This treatment is unique because it focuses on guiding patients through the cancer screening process, using trained personnel to help overcome barriers like fear, misunderstanding, and logistical issues, rather than directly treating the cancer itself. It aims to increase screening rates and early detection, especially in underserved populations, by providing personalized support and coordination. ^{2 7 9 10 11}

Research Team

Shari S Rogal, MD, MPH

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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)

I am a veteran and 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

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

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. [2023]

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

Key considerations in designing a patient navigation program for colorectal cancer screening. [2021]

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

Patient navigation: state of the art or is it science? [2022]

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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

Refining the Patient Navigation Role in a Colorectal Cancer Screening Program: Results From an Intervention Study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. [2021]

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

Colorectal Cancer Screening Navigation for the Underserved: Experience of an Urban Program. [2020]

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

Characteristics of Effective Colorectal Cancer Screening Navigation Programs in Federally Qualified Health Centers: A Systematic Review. [2018]

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

What Multilevel Interventions Do We Need to Increase the Colorectal Cancer Screening Rate to 80%? [2022]

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

Use of Evidence-Based Interventions to Address Disparities in Colorectal Cancer Screening. [2022]

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

Implementing organized colorectal cancer screening programs in Europe-protocol for a systematic review of determinants and strategies. [2023]