Colorectal Cancer Screening in a Community Health Setting

Not Applicable

Completed

• Conditions: Cancer of the Colon
• Interventions: Behavioral: Text-only; Behavioral: Text + Lottery

• Registration Number: NCT03072095
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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:

1. text messaging outreach (text)

2. 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.

Study Timeline

• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Study Start: 2017-04-17
• Primary Completion: 2017-08-03
• Study Completion: 2017-11-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

1. Between 50 and 74 years old
2. Has active medical insurance
3. Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
4. Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
5. Asymptomatic for CRC

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Exclusion Criteria

1. 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)
2. Has a history of CRC
3. Has a history of other GI cancer
4. Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis)
5. Has a history of colon polyps
6. Has had a colectomy
7. Has a first-degree relative that has been diagnosed with CRC
8. Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
9. Has been diagnosed with Familial Adenomatous Polyposis (FAP).
10. Has iron deficiency anemia
11. Has recent history of lower GI bleeding
12. Has metastatic (Stage IV) blood or solid tumor cancer
13. Has end stage renal disease
14. Has had congestive heart failure
15. Has dementia
16. Has liver cirrhosis
17. Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
18. Does not use a mobile phone enabled to send and receive text messages

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text-only	Text-only	Text-only outreach
Text + Lottery	Text + Lottery	Text outreach + financial incentive

Primary Outcome Measures

Name	Time	Method
FIT completion within 3 months	3 months	The percentage of participants who successfully complete the FIT

Secondary Outcome Measures

Name	Time	Method
Response to text-based CRC screening outreach	3 months	The percentage of people who respond to text message

Trial Locations

Locations (1)

Family Practice & Counseling Network - Health Annex; 🇺🇸 Philadelphia, Pennsylvania, United States