Cancer of the Colon Clinical Trial
Official title:
Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
NCT number | NCT03072095 |
Other study ID # | 826576 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 17, 2017 |
Est. completion date | November 3, 2017 |
Verified date | February 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 281 |
Est. completion date | November 3, 2017 |
Est. primary completion date | August 3, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 74 Years |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Family Practice & Counseling Network - Health Annex | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FIT completion within 3 months | The percentage of participants who successfully complete the FIT | 3 months | |
Secondary | Response to text-based CRC screening outreach | The percentage of people who respond to text message | 3 months |
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