Colorectal Cancer Screening in a Community Health Setting

Cancer of the Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072095
• Other study ID #: 826576
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: November 3, 2017

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cancer of the Colon
• Colonic Neoplasms
• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Family Practice & Counseling Network - Health Annex	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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