Liver Cancer Community Education
Primary Purpose
Liver Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIVE-R Life Education
Sponsored by
About this trial
This is an interventional prevention trial for Liver Cancer focused on measuring prevention, education
Eligibility Criteria
Inclusion Criteria:
- Speaks/reads English
- Lives in Philadelphia or receives healthcare at a community partner site in Philadelphia
Exclusion Criteria:
- None
Sites / Locations
- Fox Chase Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liver Cancer Education
Arm Description
Outcomes
Primary Outcome Measures
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. A positive change in mean knowledge score indicates liver cancer knowledge increased from baseline to post-intervention.
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. A positive change in mean score indicates that interest increased from baseline to post-intervention.
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. A positive change in mean score indicates that interest increased from baseline to post-intervention.
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). A positive change in mean score indicates that interest increased from baseline to post-intervention.
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. A positive change in mean score indicates that interest increased from baseline to post-intervention.
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. A positive change in mean score indicates that outcome expectancies increased from baseline to post-intervention.
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. A positive change in mean score indicates that outcome expectancies increased from baseline to post-intervention.
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. A positive change in mean score indicates that intentions increased from baseline to post-intervention.
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. A positive change in mean score indicates that intentions increased from baseline to post-intervention.
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. A positive change in mean score indicates that intentions increased from baseline to post-intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT04272619
First Posted
February 13, 2020
Last Updated
December 1, 2022
Sponsor
Fox Chase Cancer Center
Collaborators
Pennsylvania Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT04272619
Brief Title
Liver Cancer Community Education
Official Title
LIVE-R Life: Liver Cancer Education
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
Pennsylvania Department of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
prevention, education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liver Cancer Education
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
LIVE-R Life Education
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in mean liver cancer knowledge
Description
Liver cancer knowledge will be measured through four true/false items. Responses will be summed for a total liver cancer knowledge score. A positive change in mean knowledge score indicates liver cancer knowledge increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in general interest in learning about neighborhood health
Description
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. A positive change in mean score indicates that interest increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in interest in learning about neighborhood health from a healthcare provider
Description
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. A positive change in mean score indicates that interest increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in interest in learning about neighborhood health from other sources
Description
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). A positive change in mean score indicates that interest increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in interest in discussing high liver cancer risk with a healthcare provider
Description
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. A positive change in mean score indicates that interest increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in outcome expectancies for learning about neighborhood health - patient behavior
Description
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. A positive change in mean score indicates that outcome expectancies increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in outcome expectancies for learning about neighborhood health - provider behavior
Description
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. A positive change in mean score indicates that outcome expectancies increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in intentions about communicating with healthcare provider - neighborhood prevalence of liver cancer
Description
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. A positive change in mean score indicates that intentions increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in intentions about communicating with healthcare provider - liver cancer screening
Description
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. A positive change in mean score indicates that intentions increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
Title
Change in intentions about communicating with healthcare provider - liver cancer risk
Description
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. A positive change in mean score indicates that intentions increased from baseline to post-intervention.
Time Frame
Baseline, 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Speaks/reads English
Lives in Philadelphia or receives healthcare at a community partner site in Philadelphia
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon M Lynch, PhD
Phone
215-728-5377
Email
shannon.lynch@fccc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Sorice
Phone
215-214-1433
Email
kristen.sorice@fccc.edu
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Sorice
Phone
845-820-5180
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Liver Cancer Community Education
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