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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA023108-40S4 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Dartmouth College | OTHER |
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The purpose of this study is to help the Dartmouth Cancer Center and the National Cancer Institute understand how to educate people about cancer screening.
The Dartmouth Cancer Center's Community Outreach and Engagement Team will implement Screen to Save 2 using an online format. The education will be based on a set of key messages that cover information about colorectal cancer, including risk factors, prevention, screening recommendations, and screening options. Key messages provided by the National Cancer Institute will be tailored to the local context of NH and VT, including information about local options for getting screened for colorectal cancer.
Using online or telephone surveys, some participants will be contacted approximately three months after their initial participation. Some of the participants contacted after three months will again be contacted another three months later (six months after initial participation). The three- and six-month surveys will assess knowledge, attitudes, beliefs, and behaviors related to cancer screening, including outcomes from cancer screening.
The primary aim of the study is to implement and evaluate Screen to Save 2 outreach and educational activities to improve knowledge of colorectal cancer screening methods, to increase intent to get screened for colorectal cancer, and connect screening services to the target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1 | Experimental | Participants who meet eligibility criteria will be able to enroll and participate on-line, with some participating in online or telephone survey follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online educational video and website module | Other | Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Correct Responses Regarding Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening | A pre-test and post-test are conducted with participants to assess changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 true/false and multiple-choice questions, reported as a percent change in points). An increased % change in points represents increased knowledge of each survey question and a value of 0 indicates knowledge did not change (a negative value would indicate decreased knowledge). % change is a unique number that was calculated as the difference between the % answering correctly after the intervention minus the % correct before the intervention; it is representative of the entire data set and not calculated on an individual participant level. P values (<0.05) are based on chi-square tests. Each row represents a unique survey question evaluating the topic listed in the row title. | pre-test administered immediately before educational intervention; post-test administered immediately after the educational intervention on day 1. |
| Change in Colorectal Cancer Screening and Other Risk Behavior Intentions | A pre-test and post-test are conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 5-point Likert scale: strongly agree (5), agree, unsure, disagree, strongly disagree(1). The values reported represent the difference between pre-intervention and post-intervention scores, calculated as a unique number for the total responding participants (not calculated individually). A positive change represents increased intent. Each row represents a unique survey question evaluating the topic listed in the row title. | pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention on day 1 |
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Inclusion Criteria:
Exclusion Criteria:
- Cognitive impairment preventing participation in informed consent process
Three-Month Follow-Up Survey Inclusion Criteria:
A participant will be eligible for inclusion in the three-month follow-up survey if the participant completed the pre-test, educational intervention, and post-test and at the time of initial participation:
Six-Month Follow-Up Survey Inclusion Criteria:
A participant will be eligible for inclusion in the six-month follow-up survey if the participant participated in the three-month-follow up survey and at that time reported that having:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Rees, BM, BCh, MPH, PhD | Geisel School of Medicine, Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Arm 1 | Participants who meet eligibility criteria will be able to enroll and participate on-line, with some participating in online or telephone survey follow-up. Online educational video and website module: Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm 1 | Participants who meet eligibility criteria will be able to enroll and participate on-line, with some participating in online or telephone survey follow-up. Online educational video and website module: Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 Correct Responses Regarding Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening | A pre-test and post-test are conducted with participants to assess changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 true/false and multiple-choice questions, reported as a percent change in points). An increased % change in points represents increased knowledge of each survey question and a value of 0 indicates knowledge did not change (a negative value would indicate decreased knowledge). % change is a unique number that was calculated as the difference between the % answering correctly after the intervention minus the % correct before the intervention; it is representative of the entire data set and not calculated on an individual participant level. P values (<0.05) are based on chi-square tests. Each row represents a unique survey question evaluating the topic listed in the row title. | Posted | Number | Percent Change | pre-test administered immediately before educational intervention; post-test administered immediately after the educational intervention on day 1. |
|
Through study completion, an average of 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 | Experimental Arm 1 | Participants who meet eligibility criteria will be able to enroll and participate on-line, with some participating in online or telephone survey follow-up. Online educational video and website module: Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Rees | Dartmouth-Hitchcock | 603-646-5492 | Judith.R.Rees@dartmouth.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 | Sep 25, 2025 | Sep 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Educational attainment | Count of Participants | Participants |
|
| Number of Forms of Insurance | Count of Participants | Participants |
|
| Type of insurance | Count of Participants | Participants |
|
| Ever screened for CRC | Count of Participants | Participants |
|
| Number of methods of CRC screening | Count of Participants | Participants |
|
| Type of CRC screening method | Count of Participants | Participants |
|
| History of polyps | Count of Participants | Participants |
|
| History of CRC | Count of Participants | Participants |
|
| History of CRC in any first-degree relatives | Count of Participants | Participants |
|
| History of CRC in any distant relatives | Count of Participants | Participants |
|
| OG000 | Experimental Arm 1 | Participants who meet eligibility criteria will be able to enroll and participate on-line, with some participating in online or telephone survey follow-up. Online educational video and website module: Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone. |
|
|
|
| Primary | Change in Colorectal Cancer Screening and Other Risk Behavior Intentions | A pre-test and post-test are conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 5-point Likert scale: strongly agree (5), agree, unsure, disagree, strongly disagree(1). The values reported represent the difference between pre-intervention and post-intervention scores, calculated as a unique number for the total responding participants (not calculated individually). A positive change represents increased intent. Each row represents a unique survey question evaluating the topic listed in the row title. | Posted | Mean | Standard Deviation | score on a scale | pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention on day 1 |
|
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|
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| 0 |
| 205 |
| 0 |
| 205 |
| 0 |
| 205 |
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| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Eat healthier diet |
|
| Increase physical activity |
|
| Talk about CRC with family or friends |
|
| .006 |
| Other |
| Change in intention to talk to eat a healthier diet | t-test, 2 sided | .0001 | Other |
| Change in intention to increase physical activity | t-test, 2 sided | <.0001 | Other |
| Change in intention to talk about CRC with family or friends | t-test, 2 sided | <.0001 | Other |