NCT06458998

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,300

participants targeted

Target at P75+ for not_applicable

Timeline
46mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jul 2024Feb 2030

First Submitted

Initial submission to the registry

May 31, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2030

Last Updated

February 23, 2026

Status Verified

July 1, 2025

Enrollment Period

5.6 years

First QC Date

May 31, 2024

Last Update Submit

February 19, 2026

Conditions

Cancer of LiverCancer of ColonCirrhosis

Keywords

implementation strategiespatient navigationimplementation facilitationConsolidated Framework for Implementation ResearchEarly detection of cancer

Outcome Measures

Primary Outcomes (2)

  • Change in Reach of HCC screening from Baseline to 12 months

    Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of eligible Veterans in the HCC screening subgroup receiving guideline-concordant abdominal imaging within the prior 6 months.

    Baseline, 12 months from Baseline

  • Change in Reach of CRC screening from Baseline to 12 months

    Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of eligible Veterans in the CRC screening subgroup receiving a colonoscopy.

    Baseline, 12 months from Baseline

Secondary Outcomes (9)

  • Effectiveness of screening - Change in the number of tumor/polyp/lesions detected from Baseline to 12 months

    Baseline, 12 months from Baseline

  • Effectiveness of screening - Change in time to treatment from Baseline to 12 months

    Baseline, 12 months from Baseline

  • Change in Adoption of screening from Baseline to 12 months

    Baseline, 12 months from Baseline

  • Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM)

    12 months from Baseline

  • Acceptability assessed by the Acceptability of Intervention Measure (AIM)

    12 months from Baseline

  • +4 more secondary outcomes

Study Arms (2)

Patient Navigation (PN)

ACTIVE COMPARATOR

Half of the HCC sites and half of the CRC sites will be randomized to PN.

Behavioral: Patient Navigation

Implementation Facilitation (IF)

ACTIVE COMPARATOR

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.

Behavioral: Implementation Facilitation

Interventions

Patient NavigationBEHAVIORAL

Patient Navigation providers include nurses, advance practice providers, and physicians who work to improve care across a range of measures using virtual PN. Providers will 1) use existing dashboards to identify at-risk Veterans, 2) conduct Veteran outreach (two calls, one letter) to provide education, problem solve, and offer screening, 3) order and schedule HCC or CRC screening tests, and 4) provide reminders and follow up on results.

Patient Navigation (PN)
Implementation FacilitationBEHAVIORAL

Facilitators will provide 20 hours of virtual facilitation to site teams, through 1-hour meetings every other week and ad hoc meetings, over 12 months. They will guide site teams through a seven-step playbook called Getting To Implementation (GTI), which uses a series of tools to select context-specific strategies.

Implementation Facilitation (IF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans:
  • ≥18 years of age
  • Enrolled in Veterans Health Administration (VA)
  • Have ≥1 VA encounter in the prior 18 months
  • Hepatocellular cancer (HCC) screening subgroup: Diagnosis of cirrhosis in electronic medical record
  • Colorectal cancer (CRC) screening subgroup: ≥45 years of age, positive fecal immunochemical test (FIT) (or other screening 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)
  • ≥18 years of age

You may not qualify if:

  • Veterans:
  • \<18 years of age
  • Not enrolled in VA
  • No VA encounters in the prior 18 months
  • Limited life expectancy (\< 6 months), defined as having a code for hospice
  • Providers:
  • Members of the study team will not participate, even if their sites are recruited

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • Rogal SS, Yakovchenko V, Morgan TR, Dominitz JA, McCurdy H, Nobbe A, Ekanem NR, Kang C, Gonzalez RI, Park A, Anwar J, Neely B, Gibson S, Lamorte C, Bajaj JS, Patton HM, Yao Y, Gawron AJ. Comparing the effectiveness of implementation strategies to improve liver and colon cancer screening for Veterans: protocol for a large cluster-randomized implementation study. Implement Sci. 2025 Aug 9;20(1):38. doi: 10.1186/s13012-025-01448-1.

    PMID: 40783525DERIVED

MeSH Terms

Conditions

Liver NeoplasmsColonic NeoplasmsFibrosis

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Shari S Rogal, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 14, 2024

Study Start

July 15, 2024

Primary Completion (Estimated)

February 28, 2030

Study Completion (Estimated)

February 28, 2030

Last Updated

February 23, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)