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| ID | Type | Description | Link |
|---|---|---|---|
| HM20023619 | Other Identifier | Virginia Commonwealth University | |
| CA264067-01 | Other Grant/Funding Number | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/ Black men use of colorectal cancer screening and describe how community leaders such as barbers may act as Community Champions to educate and facilitate screening participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Screen to Save (S2S) content | Experimental | Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth Application | Behavioral | Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Screening Status | The number of participants that complete screening (any type) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Feasibility of Mobile Health (mHealth) Application -Enrollment | The number of men that enroll for the intervention (application) | Week 1 |
| Determine the Feasibility of the mHealth Application-Videos |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Thomson, Ph.D. | Virginia Commonwealt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39388688 | Derived | Thomson MD, Shahab GH, Cooper-McGill CA, Sheppard VB, Hill SS, Preston M, Keen Ii L. Increasing Colorectal Cancer Screening Among Black Men in Virginia: Development of an mHealth Intervention. JMIR Form Res. 2024 Oct 10;8:e50028. doi: 10.2196/50028. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Screen to Save (S2S) Content | Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones. mHealth Application: Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Screen to Save (S2S) Content | Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones. mHealth Application: Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Colorectal Screening Status | The number of participants that complete screening (any type) | Posted | Count of Participants | Participants | 3 Months |
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Adverse events were not collected for this trial.
Adverse events were not collected for this trial.
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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 | Tailored Screen to Save (S2S) Content | Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones. mHealth Application: Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Thomson | Virginia Commonwealth University | 804-628-2640 | mthomson2@vcu.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 8, 2021 | Jun 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2023 | Jun 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
The number of participants that view the videos
| Week 1 |
| Determine the Feasibility of the mHealth Application- Retention | The number of participants that complete Questionnaires (>65%) | Baseline (Day 1), Week 2, and Week 12 |
| Determine the Feasibility of the mHealth Application- Clinic/ Screening Request | The number of participants that respond to the request to contact clinic/ navigation services | Week 12 |
| Determine the Feasibility of the mHealth Application - Sharing Content | The number of participants that share content on social network | Week 12 |
| Participants |
|
| 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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| Secondary | Determine Feasibility of Mobile Health (mHealth) Application -Enrollment | The number of men that enroll for the intervention (application) | Posted | Count of Participants | Participants | Week 1 |
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| Secondary | Determine the Feasibility of the mHealth Application-Videos | The number of participants that view the videos | Posted | Count of Participants | Participants | Week 1 |
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|
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| Secondary | Determine the Feasibility of the mHealth Application- Retention | The number of participants that complete Questionnaires (>65%) | Number of participants that completed questionnaires during specified timepoints. | Posted | Number | participants | Baseline (Day 1), Week 2, and Week 12 |
|
|
|
| Secondary | Determine the Feasibility of the mHealth Application- Clinic/ Screening Request | The number of participants that respond to the request to contact clinic/ navigation services | Posted | Count of Participants | Participants | Week 12 |
|
|
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| Secondary | Determine the Feasibility of the mHealth Application - Sharing Content | The number of participants that share content on social network | Posted | Count of Participants | Participants | Week 12 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Title | Measurements |
|---|---|
|