Cancer of LiverGTINCT06458998
Getting To Implementation: Improving Cancer Screening for Veterans
A study testing Patient Navigation and Implementation Facilitation in people with Cancer of Liver and Cancer of Colon, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Liver, Cancer of Colon, Cirrhosis
- What is being tested?
- Patient Navigation and Implementation Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 28 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Getting To Implementation: Comparing the Effectiveness of Implementation Strategies to Improve Cancer Screening for Veterans
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.
Read the detailed description
Researchers will conduct two hybrid type 3, cluster-randomized trials to compare the effectiveness of Patient Navigation (PN) and Implementation Facilitation (IF) on hepatocellular cancer (HCC) and colorectal cancer (CRC) screening completion. Trials will enroll 24 sites for the HCC arm and 32 sites for the CRC arm, passively enrolling and cluster-randomizing Veterans by their site of primary care. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will also be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants. Comparing findings in the two trials will allow researchers to understand how the barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC).
- Conditions
- Cancer of Liver, Cancer of Colon, Cirrhosis
- Being tested
- Patient Navigation, Implementation Facilitation
- Keywords
- implementation strategies, patient navigation, implementation facilitation, Consolidated Framework for Implementation Research, Early detection of cancer
- Medical subject headings
- Liver Neoplasms, Colonic Neoplasms, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
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 (e.g., 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.
Implementation FacilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation (PN) | Active comparator | Half of the HCC sites and half of the CRC sites will be randomized to PN. Receives: 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. Receives: Behavioral: Implementation Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Effectiveness is the impact of an intervention on important individual outcomes, defined as detection of cancer.
Measured: Baseline, 12 months from Baseline
Effectiveness of screening - Change in time to treatment from Baseline to 12 months
Effectiveness is the impact of an intervention on important individual outcomes, defined as time to treatment, which will be measured from the date of cancer diagnosis to the date of referral.
Measured: Baseline, 12 months from Baseline
Change in Adoption of screening from Baseline to 12 months
Adoption is the absolute number, proportion, and representativeness of settings/people who are willing to initiate a program. Site-level adoption will be defined as meeting the national goal of 65% HCC screening and 80% linkage to colonoscopy within 6-months of positive stool-based screening.
Measured: Baseline, 12 months from Baseline
Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM)
Feasibility refers to the extent to which an intervention can be successfully used within a given setting, as measured by the Feasibility of Intervention Measure (FIM) assessment. The FIM is a 4-item measure, with each item scored using a 5-point Likert scale. Scores range from a minimum of 4 points to a maximum of 20. Higher scores indicate greater feasibility.
Measured: 12 months from Baseline
Acceptability assessed by the Acceptability of Intervention Measure (AIM)
Acceptability refers to a given intervention being perceived as agreeable, palatable, or satisfactory by implementation stakeholders, as measured by the Acceptability of Intervention Measure (AIM). The AIM is a 4-item measure, with each item scored using a 5-point Likert scale. Scores range from a minimum of 4 points to a maximum of 20. Higher scores indicate greater acceptability.
Measured: 12 months from Baseline
Appropriateness assessed by the Intervention Appropriateness Measure (IAM)
Appropriateness is the perceived fit of an intervention to address a particular issue or problem, as measured by the Intervention Appropriateness Measure (IAM). The IAM is a 4-item measure, with each item scored using a 5-point Likert scale. Scores range from a minimum of 4 points to a maximum of 20. Higher scores indicate greater appropriateness.
Measured: 12 months from Baseline
Fidelity - Proportion of Veterans receiving recommended screening
Fidelity is the degree to which an intervention/innovation is delivered as intended. Fidelity of cancer screenings will be assessed by the proportion of Veterans at a given site receiving HCC or CRC screening as recommended (correct timing and modality). Fidelity to core strategy elements will be evaluated using checklists.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Maintenance of HCC Screening at 18 and 24 months from Baseline
Maintenance is the extent to which a program becomes part of routine organizational practices. Sustainment of HCC Screening will be measured by the percentage of eligible Veterans in the HCC screening subgroup receiving guideline-concordant abdominal imaging within the prior 6 months.
Measured: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)
Maintenance of CRC Screening at 18 and 24 months from Baseline
Maintenance is the extent to which a program becomes part of routine organizational practices. Sustainment of CRC Screening will be measured by the percentage of eligible Veterans in the CRC screening subgroup receiving a colonoscopy.
Measured: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jul 2024
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of LiverStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Shari Rogal, University of Pittsburgh
- Investigators
- Shari S Rogal, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458998
- Sponsor's protocol ID
- STUDY24010054
- Other IDs
- 1792560, BPS-2023C1-31034
- Acronym
- GTI
- Status last verified
- Jul 2026
- First submitted
- 31 May 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40783525
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting To Implementation: Comparing the Effectiveness of Implementation Strategies to Improve Cancer Screening for Veterans
- ClinicalTrials.gov ID
- NCT06458998
- Acronym / sponsor ID
- GTI / STUDY24010054
- Conditions
- Cancer of Liver, Cancer of Colon, Cirrhosis
- Keywords
- implementation strategies, patient navigation, implementation facilitation, Consolidated Framework for Implementation Research, Early detection of cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30,300 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Researchers will conduct two hybrid type 3, cluster-randomized trials to compare the effectiveness of Patient Navigation (PN) and Implementation Facilitation (IF) on hepatocellular cancer (HCC) and colorectal cancer (CRC) screening completion. Trials will enroll 24 sites for the HCC arm and 32 sites for the CRC arm, passively enrolling and cluster-randomizing Veterans by their site of primary care. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will also be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants. Comparing findings in the two trials will allow researchers to understand how the barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation (PN) | Active comparator | Behavioral: Patient NavigationHalf of the HCC sites and half of the CRC sites will be randomized to PN. |
| Implementation Facilitation (IF) | Active comparator | Behavioral: Implementation FacilitationHalf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Veterans:
- Providers:
Key exclusion criteria (7 listed)
- Veterans:
- Providers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationPatient 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 (e.g., 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. | Behavioural | Patient Navigation (PN) |
| Implementation FacilitationFacilitators 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. | Behavioural | Implementation Facilitation (IF) |
Primary outcome
Change in Reach of HCC screening from Baseline to 12 months
Time frame: Baseline, 12 months from Baseline
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.
Change in Reach of CRC screening from Baseline to 12 months
Time frame: Baseline, 12 months from Baseline
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.
9 secondary outcomes
Effectiveness of screening - Change in the number of tumor/polyp/lesions detected from Baseline to 12 months
Time frame: Baseline, 12 months from Baseline
Effectiveness of screening - Change in time to treatment from Baseline to 12 months
Time frame: Baseline, 12 months from Baseline
Change in Adoption of screening from Baseline to 12 months
Time frame: Baseline, 12 months from Baseline
Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM)
Time frame: 12 months from Baseline
Acceptability assessed by the Acceptability of Intervention Measure (AIM)
Time frame: 12 months from Baseline
Appropriateness assessed by the Intervention Appropriateness Measure (IAM)
Time frame: 12 months from Baseline
Fidelity - Proportion of Veterans receiving recommended screening
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Maintenance of HCC Screening at 18 and 24 months from Baseline
Time frame: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)
Maintenance of CRC Screening at 18 and 24 months from Baseline
Time frame: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 40783525Rogal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari S Rogal, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation and Implementation Facilitation in people with Cancer of Liver and Cancer of Colon, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reach of HCC screening from Baseline to 12 months (time frame: Baseline, 12 months from Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06458998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.