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OpenTrials
Completed

NCT Number: NCT03072095

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.

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Practice & Counseling Network - Health Annex

Philadelphia, Pennsylvania, 19142, United States

About this study

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:

  • text messaging outreach (text)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 50 and 74 years old
  • Has active medical insurance
  • Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
  • Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
  • Asymptomatic for CRC

Exclusion criteria

  • 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)
  • Has a history of CRC
  • Has a history of other GI cancer
  • Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis)
  • Has a history of colon polyps
  • Has had a colectomy
  • Has a first-degree relative that has been diagnosed with CRC
  • Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  • Has been diagnosed with Familial Adenomatous Polyposis (FAP).
  • Has iron deficiency anemia
  • Has recent history of lower GI bleeding
  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has had congestive heart failure
  • Has dementia
  • Has liver cirrhosis
  • Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
  • Does not use a mobile phone enabled to send and receive text messages

Treatment and study plan

Text-only

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

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.

Primary outcomes

  1. FIT completion within 3 months

    Time frame: 3 months

    The percentage of participants who successfully complete the FIT

Secondary outcomes

  1. Response to text-based CRC screening outreach

    Time frame: 3 months

    The percentage of people who respond to text message

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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