Colorectal Cancer Screening in a Community Health Setting

February 19, 2019 updated by: Shivan J Mehta, University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

281

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19142
        • Family Practice & Counseling Network - Health Annex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FIT completion within 3 months
Time Frame: 3 months
The percentage of participants who successfully complete the FIT
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to text-based CRC screening outreach
Time Frame: 3 months
The percentage of people who respond to text message
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2017

Primary Completion (Actual)

August 3, 2017

Study Completion (Actual)

November 3, 2017

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 826576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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