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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA023108-39 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research is to understand if an educational program about colorectal cancer helps improve people's knowledge of colorectal cancer prevention and screening and their intention to get screened for colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflatable colon educational module | Experimental | Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflatable colon educational module | Behavioral | Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening | A pre-test and post-test is conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 questions before and after learning). | Baseline and immediately following intervention |
| Number of Participants With Varying Levels of Behavioral Intentions Related to Colorectal Cancer Screening and Prevention | Post-test conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 4-point Likert scale, where a higher score indicates stronger behavioral intention). The scale for all behavioral intention measures started with, "As a result of the colorectal cancer screening information I received during the Screen to Save educational session, I am more likely to…" | Immediately following intervention |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Onega, PhD, MA, MS | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
All of the individual de-identified data collected during the trial will be shared with the National Cancer Institute, Geographic Management of Cancer Health Disparities Program (GMaP) contacts, and NCI's designated contractor for the Screen to Save Initiative
Immediately following data collection events
For meta-analyses
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| ID | Title | Description |
|---|---|---|
| FG000 | Inflatable Colon Educational Module | Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer. Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inflatable Colon Educational Module | Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer. Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening. |
| 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, Customized | Two participants did not provide their age in the baseline survey. |
| 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 Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening | A pre-test and post-test is conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 questions before and after learning). | Posted | Median | Full Range | score on a scale | Baseline and immediately following intervention |
|
During presentation, up to 1 day
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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 | Inflatable Colon Educational Module | Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer. Inflatable colon educational module: Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Community Education and Prevention | Dartmouth-Hitchcock Norris Cotton Cancer Center | 603-653-9960 | nccc.community.outreach@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2017 | Jun 24, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2017 | Jun 24, 2020 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2020 | Jul 9, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| Correct Answers on Knowledge Questions | Number of correct responses to a series of 14 true/false and multiple-choice test questions about colorectal cancer risks, prevention, and screening. | Mean | Standard Deviation | correct answers |
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| Primary | Number of Participants With Varying Levels of Behavioral Intentions Related to Colorectal Cancer Screening and Prevention | Post-test conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 4-point Likert scale, where a higher score indicates stronger behavioral intention). The scale for all behavioral intention measures started with, "As a result of the colorectal cancer screening information I received during the Screen to Save educational session, I am more likely to…" | Four intention questions were left blank/unanswered by one to two participants each. | Posted | Count of Participants | Participants | Immediately following intervention |
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|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Disagree |
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| Strongly Disagree |
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| Intent to get screened for CRC |
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| Intent to talk w/ family/friends about screening |
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| Intent to eat healthier |
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| Intent to increase physical activity |
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