Colorectal Cancer Screening in a Community Health Setting

Study Overview
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Brief Summary
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This randomized controlled pilot study at the Health Annex, Family Practice & Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Detailed Description
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This is a single-center RCT at the Family Practice & Counseling Network (FPCN), a community clinic in Southwest Philadelphia with 320 eligible subjects between the ages of 50-74 randomized to two study arms: text messaging outreach (text) text messaging outreach with lottery for 1/5 chance to win a financial incentive (text + lottery). Findings will provide data on the feasibility of this mailed FIT approach in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Official Title
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Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting

Conditions
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Cancer of the Colon

Intervention / Treatment
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* Behavioral: Text-only
* Behavioral: Text + Lottery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 50 and 74 years old Has active medical insurance Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review) Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year) Asymptomatic for CRC Exclusion Criteria: Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and FOBT/FIT within twelve months of the chart review (we will exclude patients who self-report undergoing any of the above procedures) Has a history of CRC Has a history of other GI cancer Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis) Has a history of colon polyps Has had a colectomy Has a first-degree relative that has been diagnosed with CRC Has been diagnosed with Lynch Syndrome (i.e. HNPCC) Has been diagnosed with Familial Adenomatous Polyposis (FAP). Has iron deficiency anemia Has recent history of lower GI bleeding Has metastatic (Stage IV) blood or solid tumor cancer Has end stage renal disease Has had congestive heart failure Has dementia Has liver cirrhosis Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study Does not use a mobile phone enabled to send and receive text messages

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text-only<br>Text-only outreach | Behavioral: Text-only<br>* Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit.<br>|
| Experimental: Text + Lottery<br>Text outreach + financial incentive | Behavioral: Text + Lottery<br>* Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit and a 1 in 5 chance to win a $100 gift card for completing the kit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIT completion within 3 months | The percentage of participants who successfully complete the FIT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to text-based CRC screening outreach | The percentage of people who respond to text message | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms, Colonic Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Rectal Diseases