Colorectal Cancer Screening in a Community Health Setting

NCT ID: NCT03072095

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2017-11-03

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.

Conditions

Cancer of the Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Text-only

Text-only outreach

Group Type: EXPERIMENTAL

Text-only

Intervention Type: BEHAVIORAL

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

Text outreach + financial incentive

Group Type: EXPERIMENTAL

Text + Lottery

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Shivan J Mehta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Family Practice & Counseling Network - Health Annex

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32477853 (View on PubMed)

Other Identifiers

826576

Identifier Type: -

Identifier Source: org_study_id