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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Cancer Education | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIVE-R Life Education | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liver Cancer Education | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liver Cancer Education | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Five participants skipped the knowledge items on either the pre-test or the post-test. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
|
One hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liver Cancer Education | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Sorice | Fox Chase Cancer Center | 215-214-1433 | kristen.sorice@fccc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 | Sep 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | Two participants did not answer this item at pre- or post-test. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | Three participants did not respond to this item at pre- or post-survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | One participant did not answer this item at pre- or post-survey | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | Two participants did not respond to this item at pre- or post-survey | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | One participants did not answer this item at pre- or post-survey | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| Primary | 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. | Four participants did not respond to this item at pre- or post-survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 30 minutes |
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| D008107 |
| Liver Diseases |