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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-00144 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R21AG061496 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This clinical trial compares audio brochures and video brochures to usual care for increasing colorectal cancer (CRC) screening among adults living in Appalachia. Adults living in rural Appalachia experience increased rates of CRC, possibly due to the unique barriers to screening this population faces, such as lower socioeconomic status, limited health literacy, and less access to healthcare. The fecal immunochemical test (FIT) is a common CRC screening technique which allows individuals to complete the test at home and mail the kit back. A limitation of the current process for FIT screening outreach is that the instruction materials are heavy in text and not appropriate for individuals with limited health literacy. The audio and video brochures used in this clinical trial are instruction materials that have been specially designed to be appropriate for individuals of all health literacy levels. Providing these audio and video brochures with the FIT kits may increase CRC screening among adults living in Appalachia, compared to usual care.
PRIMARY OBJECTIVE:
I. Conduct a pilot study of the two developed mail-based FIT outreach interventions versus (vs.) mailed usual care materials to establish acceptability and obtain preliminary efficacy data on increasing CRC screening.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants receive the FIT kit and usual care on study.
ARM II: Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
ARM III: Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (FIT, usual care) | Active Comparator | Participants receive the FIT kit and usual care on study. |
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| Arm II (FIT, audio brochure, reminder) | Experimental | Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. |
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| Arm III (FIT, video brochure, reminder) | Experimental | Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants to Return Fecal Immunochemical Test (FIT) | Will estimate FIT return using proportions for each study group. Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study. | At 2 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mira Katz, PhD, MPH | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37296510 | Result | Katz ML, Shoben AB, Newell S, Hall C, Emerson B, Gray DM 2nd, Chakraborty S, Reiter PL. Video brochures in a mailed fecal immunochemical test outreach program provide cancer screening information in a user-friendly format for rural Appalachian community members. J Rural Health. 2024 Jan;40(1):96-103. doi: 10.1111/jrh.12772. Epub 2023 Jun 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (FIT, Usual Care) | Participants receive the FIT kit and usual care on study. Best Practice: Receive usual care Fecal Immunochemical Test: Receive FIT kit Survey Administration: Ancillary studies |
| FG001 | Arm II (FIT, Audio Brochure, Reminder) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 26, 2022 |
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| Fecal Immunochemical Test | Other | Receive FIT kit |
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| Health Education | Behavioral | Receive audio brochure |
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| Health Education | Behavioral | Receive video brochure |
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| Scheduled Notification | Other | Receive scheduled reminder |
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| Survey Administration | Other | Ancillary studies |
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Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive audio brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies |
| FG002 | Arm III (FIT, Video Brochure, Reminder) | Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive video brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (FIT, Usual Care) | Participants receive the FIT kit and usual care on study. Best Practice: Receive usual care Fecal Immunochemical Test: Receive FIT kit Survey Administration: Ancillary studies |
| BG001 | Arm II (FIT, Audio Brochure, Reminder) | Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive audio brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies |
| BG002 | Arm III (FIT, Video Brochure, Reminder) | Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive video brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies |
| BG003 | Total | Total of all reporting groups |
| 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 | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants to Return Fecal Immunochemical Test (FIT) | Will estimate FIT return using proportions for each study group. Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study. | Posted | Count of Participants | Participants | At 2 months |
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Adverse event data was collected for up to 60 days.
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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 | Arm I (FIT, Usual Care) | Participants receive the FIT kit and usual care on study. Best Practice: Receive usual care Fecal Immunochemical Test: Receive FIT kit Survey Administration: Ancillary studies | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Arm II (FIT, Audio Brochure, Reminder) | Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive audio brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | Arm III (FIT, Video Brochure, Reminder) | Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive video brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies | 0 | 32 | 0 | 32 | 0 | 32 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mira Katz | The Ohio State University Comprehensive Cancer Center | 614-293-6603 | Mira.katz@osumc.edu |
| Dec 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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