Liver CancerNCT04272619
Liver Cancer Community Education
A study testing LIVE-R Life Education in people with Liver Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer
- What is being tested?
- LIVE-R Life Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speaks/reads English
- Lives in Philadelphia or receives healthcare at a community partner site in Philadelphia
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: 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.
- Conditions
- Liver Cancer
- Being tested
- LIVE-R Life Education
- Keywords
- prevention, education
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIVE-R Life EducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Liver Cancer Education | Experimental | Not described Receives: Behavioral: LIVE-R Life Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start11 Feb 2020
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272619
- Sponsor's protocol ID
- 19-1039
- Status last verified
- Nov 2024
- First submitted
- 13 Feb 2020
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIVE-R Life: Liver Cancer Education
- ClinicalTrials.gov ID
- NCT04272619
- Acronym / sponsor ID
- 19-1039
- Conditions
- Liver Cancer
- Keywords
- prevention, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Cancer Education | Experimental | Behavioral: LIVE-R Life Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Speaks/reads English
- Lives in Philadelphia or receives healthcare at a community partner site in Philadelphia
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| LIVE-R Life EducationA 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). | Behavioural | Liver Cancer Education |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIVE-R Life Education in people with Liver Cancer, run by Fox Chase Cancer Center 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Mean Liver Cancer Knowledge (time frame: Baseline, 30 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2025.