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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA282162 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The proposed study is examining strategies for optimizing mailed fecal immunochemical test (FIT) programs. In doing so, it will assess the efficacy of two promising strategies, FIT kit materials and patient navigation delivery mode. These strategies may help to improve colorectal cancer screening rates.
PRIMARY OBJECTIVES:
Determine the efficacy of two strategies for increasing colorectal cancer screening.
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I: Participants receive a standard FIT kit plus telephone patient navigation.
GROUP II: Participants receive a standard FIT kit plus text message patient navigation.
GROUP III: Participants receive an enhanced FIT kit plus telephone patient navigation.
GROUP IV: Participants receive an enhanced FIT kit plus text message patient navigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (standard FIT kit plus telephone PN) | Experimental | Participants receive standard FIT kit plus telephone patient navigation (PN) |
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| Group B (standard FIT kit plus text message PN) | Experimental | Participants receive standard FIT kit plus text message patient navigation (PN) |
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| Group C (enhanced FIT kit plus telephone PN) | Experimental | Participants receive enhanced FIT kit plus telephone patient navigation (PN) |
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| Group D (enhanced FIT kit plus text message PN) | Experimental | Participants receive enhanced FIT kit plus text message patient navigation (PN) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard FIT kit | Behavioral | Receive a standard FIT kit |
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| Measure | Description | Time Frame |
|---|---|---|
| FIT Return | Proportion of participants who return of a completed FIT kit | Within 8 weeks of FIT kit distribution |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Paul Reiter, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Participants are not aware of the research questions being tested in the trial.
| Enhanced FIT kit | Behavioral | Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device |
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| Telephone patient navigation | Behavioral | Receive telephone-based patient navigation |
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| Text message patient navigation | Behavioral | Receive text message-based patient navigation |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |