NCT04272619

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 8, 2025

Completed
Last Updated

January 8, 2025

Status Verified

November 1, 2024

Enrollment Period

3.2 years

First QC Date

February 13, 2020

Results QC Date

September 23, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

preventioneducation

Outcome Measures

Primary Outcomes (10)

  • Change in Mean Liver Cancer Knowledge

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (1)

Liver Cancer Education

EXPERIMENTAL
Behavioral: LIVE-R Life Education

Interventions

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).

Liver Cancer Education

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Results Point of Contact

Title
Kristen Sorice
Organization
Fox Chase Cancer Center

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

February 11, 2020

Primary Completion

April 6, 2023

Study Completion

April 6, 2023

Last Updated

January 8, 2025

Results First Posted

January 8, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations