Liver Cancer Community Education

November 20, 2024 updated by: Fox Chase Cancer Center

LIVE-R Life: Liver Cancer Education

This study proposes to bridge the gap between evidence and action and combat rising liver cancer rates attributed to Hepatitis B and C infection in Philadelphia by identifying neighborhoods with higher than expected rates of liver cancer and related risk factors and administering an educational intervention about liver cancer and neighborhood health in those communities, working with existing community partners at Fox Chase Cancer Center.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Speaks/reads English
  • Lives in Philadelphia or receives healthcare at a community partner site in Philadelphia

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Liver Cancer Education
Behavioral: LIVE-R Life Education
A health educator will present participants with a 30-minute PowerPoint presentation containing educational information about liver cancer risk, screening, prevention, symptoms, and treatments, as well as introduce the concept of neighborhood health (e.g., rates of liver cancer and related risk factors in a census tract and how that might influence individual cancer risk).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Mean Liver Cancer Knowledge
Time Frame: Baseline, 30 minutes
Liver cancer knowledge will be measured through four true/false items. Responses will be summed for a total liver cancer knowledge score. Score ranges run from 0-4, with higher scores indicating more knowledge. Change in knowledge is measured by subtracting baseline knowledge score from the post-intervention knowledge score. Change scores may range from -4 to 4, with positive scores indicating an increase in knowledge. Higher positive scores indicate a larger increase in knowledge.
Baseline, 30 minutes
Change in General Interest in Learning About Neighborhood Health
Time Frame: Baseline, 30 minutes
General interest in learning about neighborhood health will be measured through a single item asking, on a scale from strongly agree to strongly disagree, whether the participant would like to learn about liver cancer in their own neighborhood. Scores range from 1 to 5, with higher scores indicating more interest in learning about neighborhood health from a healthcare provider. Change in interest is measured by subtracting the baseline interest score from the post-intervention interest score. Change scores may range from -4 to 4, with positive scores indicating an increase in interest. Higher positive scores indicate a larger increase in interest.
Baseline, 30 minutes
Change in Interest in Learning About Neighborhood Health From a Healthcare Provider
Time Frame: Baseline, 30 minutes
Interest in learning about neighborhood health from a healthcare provider will be measured through a single item asking, on a scale from strongly agree to strongly disagree, whether the participant would like to learn about liver cancer in their own neighborhood from their doctor. Scores range from 1 to 5, with higher scores indicating more interest in learning about neighborhood health from a healthcare provider. Change in interest is measured by subtracting the baseline interest score from the post-intervention interest score. Change scores may range from -4 to 4, with positive scores indicating an increase in interest. Higher positive scores indicate a larger increase in interest.
Baseline, 30 minutes
Change in Interest in Learning About Neighborhood Health From Other Sources
Time Frame: Baseline, 30 minutes
Interest in learning about neighborhood health from other sources will be measured through a single item asking, on a scale from strongly agree to strongly disagree, whether the participant would like to learn about liver cancer in their own neighborhood from non-medical sources (e.g., website or brochure). Scores range from 1 to 5, with higher scores indicating more interest in learning about neighborhood health from other sources. Change in interest is measured by subtracting the baseline interest score from the post-intervention interest score. Change scores may range from -4 to 4, with positive scores indicating an increase in interest. Higher positive scores indicate a larger increase in interest.
Baseline, 30 minutes
Change in Interest in Discussing High Liver Cancer Risk With a Healthcare Provider
Time Frame: Baseline, 30 minutes
Interest in discussing high liver cancer risk with a healthcare provider will be measured through a single item asking, on a scale from strongly agree to strongly disagree, whether the participant would be likely to discuss their liver cancer risk with a doctor if they learned they lived in a high-risk area. Scores range from 1 to 5, with higher scores indicating more interest in discussing liver cancer risk with a healthcare provider. Change in interest is measured by subtracting the baseline interest score from the post-intervention interest score. Change scores may range from -4 to 4, with positive scores indicating an increase in interest. Higher positive scores indicate a larger increase in interest.
Baseline, 30 minutes
Change in Outcome Expectancies for Learning About Neighborhood Health - Patient Behavior
Time Frame: Baseline, 30 minutes
Patient outcome expectancies for learning about neighborhood health will be measured through a single item asking, on a scale from 0 (not at all) to 10 (very much), whether learning about neighborhood health will help the participant make health decisions. Higher scores indicate more positive expectations. Change in outcomes expectancies is measured by subtracting the baseline score from the post-intervention score. Change scores may range from -10 to 10, with positive scores indicating an increase in outcome expectancies. Higher positive scores indicate a larger increase in expectations.
Baseline, 30 minutes
Change in Outcome Expectancies for Learning About Neighborhood Health - Provider Behavior
Time Frame: Baseline, 30 minutes
Provider outcome expectancies for learning about neighborhood health will be measured through a single item asking, on a scale from 0 (not at all) to 10 (very much), whether learning about neighborhood health will help the participant's healthcare provider make health decisions for them. Higher scores indicate more positive expectations. Change in outcome expectancies is measured by subtracting the baseline score from the post-intervention score. Change scores may range from -10 to 10, with positive scores indicating an increase in outcome expectancies. Higher positive scores indicate a larger increase in expectations.
Baseline, 30 minutes
Change in Intentions About Communicating With Healthcare Provider - Neighborhood Prevalence of Liver Cancer
Time Frame: Baseline, 30 minutes
intentions about communicating with healthcare provider about neighborhood liver cancer will be measured through a single item asking, on a scale from very likely to not at all likely, how likely the participant is to discuss liver cancer in their neighborhood with their healthcare provider over the next 12 months. Scores range from 1 to 5, with higher scores indicating higher likelihood of talking to a healthcare provider. Change in intentions is measured by subtracting the baseline score from the post-intervention score. Change scores may range from -4 to 4, with positive scores indicating an increase in intentions. Higher positive scores indicate a larger increase in intentions.
Baseline, 30 minutes
Change in Intentions About Communicating With Healthcare Provider - Liver Cancer Screening
Time Frame: Baseline, 30 minutes
intentions about communicating with healthcare provider about liver cancer screening will be measured through a single item asking, on a scale from very likely to not at all likely, how likely the participant is to discuss liver cancer screening with their healthcare provider over the next 12 months. Scores range from 1 to 5, with higher scores indicating higher likelihood of talking to a healthcare provider. Change in intentions is measured by subtracting the baseline score from the post-intervention score. Change scores may range from -4 to 4, with positive scores indicating an increase in intentions. Higher positive scores indicate a larger increase in intentions.
Baseline, 30 minutes
Change in Intentions About Communicating With Healthcare Provider - Liver Cancer Risk
Time Frame: Baseline, 30 minutes
intentions about communicating with healthcare provider about liver cancer risk will be measured through a single item asking, on a scale from very likely to not at all likely, how likely the participant is to discuss their personal risk factors for liver cancer with their healthcare provider over the next 12 months. Scores range from 1 to 5, with higher scores indicating higher likelihood of talking to a healthcare provider. Change in intentions is measured by subtracting the baseline score from the post-intervention score. Change scores may range from -4 to 4, with positive scores indicating an increase in intentions. Higher positive scores indicate a larger increase in intentions.
Baseline, 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fox Chase Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pennsylvania Department of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-1039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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