Colorectal Cancer Screening in a Community Health Setting

• ClinicalTrials.gov Identifier: NCT03072095
• Recruitment Status: Completed
• First Posted: March 7, 2017
• Last Update Posted: February 20, 2019
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): Shivan J Mehta, University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer of the Colon	Behavioral: Text-only; Behavioral: Text + Lottery	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 281 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Screening
• Official Title: Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
• Actual Study Start Date: April 17, 2017
• Actual Primary Completion Date: August 3, 2017
• Actual Study Completion Date: November 3, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Text-only; Text-only outreach	Behavioral: Text-only; 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.
Experimental: Text + Lottery; Text outreach + financial incentive	Behavioral: Text + Lottery; 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.

Outcome Measures

Primary Outcome Measures :

1. FIT completion within 3 months [ Time Frame: 3 months ]
   The percentage of participants who successfully complete the FIT

Secondary Outcome Measures :

1. Response to text-based CRC screening outreach [ Time Frame: 3 months ]
   The percentage of people who respond to text message

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

Family Practice & Counseling Network - Health Annex

Philadelphia, Pennsylvania, United States, 19142

Sponsors and Collaborators

University of Pennsylvania

Investigators

• Principal Investigator: Shivan Mehta, MD; University of Pennsylvania

More Information

• Responsible Party: Shivan J Mehta, Principal Investigator, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03072095 History of Changes
• Other Study ID Numbers: 826576
• First Posted: March 7, 2017
• Last Update Posted: February 20, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shivan J Mehta, University of Pennsylvania:

Colorectal Neoplasms; Colonic Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Rectal Diseases

Additional relevant MeSH terms:

Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases