Clinical trial NCT03072095: Colorectal Cancer Screening in a Community Health Setting
Official title: Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Colon
Keywords: Colorectal Neoplasms
Colonic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 281
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: FIT completion within 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Response to text-based CRC screening outreach
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Family Practice & Counseling Network - Health Annex
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta SJ, Oyalowo A, Reitz C, Dean O, McAuliffe T, Asch DA, Doubeni CA. Text messaging and lottery incentive to improve colorectal cancer screening outreach at a community health center: A randomized controlled trial. Prev Med Rep. 2020 May 8;19:101114. doi: 10.1016/j.pmedr.2020.101114. eCollection 2020 Sep.