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| ID | Type | Description | Link |
|---|---|---|---|
| UH3CA233282 | U.S. NIH Grant/Contract | View source | |
| 832127323 | Other Identifier | DUNS - The Ohio State University |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Ohio State University | OTHER |
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This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-level Intervention | Experimental | Receives the project intervention first |
|
| Delayed Multi-level Intervention | No Intervention | Offered the intervention later in the project |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-level intervention to increase CRC screening | Behavioral | Intervention for the community, providers, patients, clinics and systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| CRC screening - clinic level | Change in clinic-level screening rate from baseline to the end of the 12-month active intervention period, assessed through clinic electronic health record data | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| CRC screening - community level | Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
.no exclusions based on gender, race or ethnicity
Self-report of gender
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| Name | Affiliation | Role |
|---|---|---|
| Mark B Dignan, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markey Cancer Center | Lexington | Kentucky | 40536 | United States | ||
| Ohio State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37202831 | Derived | Paskett ED, Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Gray DM, Pennell ML, Huang B, Young GS, Fickle D, Cromo M, Katz ML, Reiter PL, Rogers M, Gross DA, Fairchild V, Xu W, Carman A, Walunis JM, McAlearney AS, Huerta TR, Rahurkar S, Biederman E, Dignan M. Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial. Transl Behav Med. 2023 Sep 28;13(10):748-756. doi: 10.1093/tbm/ibad017. | |
| 34011410 |
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As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium.
Dataset Items in the LDS are defined by the Common Data Elements.
There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers.
In addition, all data that underlie results in publications will be available per Notice of Award.
Baseline data available beginning 10/2020, follow-up data available 12/2023
There are 2 classes of dataset requests: 1) public use and 2) special. Requestors submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use data set containing common data elements will be made available to external researchers by application. IMS responds to public use dataset application by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must first submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive review by NCI and Research Triangle Institute (RTI) before being forwarded to the SC for review and approval. Requestors report every 6 months on published articles or conference presentations to RTI. Requestors also are encouraged to make articles available through PubMed Central website.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2026 | |
| Reset | Apr 16, 2026 | |
| Release | Apr 28, 2026 | |
| Reset | May 22, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2019 | Oct 9, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Apr 16, 2026 | |||
| Apr 28, 2026 |
| 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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Primary care clinics randomized to intervention or usual care
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Primary care clinics randomized to usual care do not receive intervention materials or attention
| Columbus |
| Ohio |
| 43210 |
| United States |
| Derived |
| Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Katz ML, Reiter PL, Gray DM 2nd, Pennell ML, Young GS, Huang B, Fickle D, Cromo M, Rogers M, Gross D, Gibson A, Jellison J, Sarap MD, Bivens TA, McGuire TD, McAlearney AS, Huerta TR, Rahurkar S, Paskett ED, Dignan M. Development of a multilevel intervention to increase colorectal cancer screening in Appalachia. Implement Sci Commun. 2021 May 19;2(1):51. doi: 10.1186/s43058-021-00151-8. |
| May 22, 2026 |
| Jun 25, 2026 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |