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OpenTrials
Completed

NCT Number: NCT02929186

Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach

This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).

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Key information

About this study

This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms:

  • Opt-In - subject must actively choose to receive a home FIT kit.
  • Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 50 to 74 years old
  • Has received care at the Division of Internal Medicine
  • Due for screening
  • Asymptomatic for colorectal cancer (CRC)

Exclusion criteria

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (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. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
  • Has history of colitis other than Crohn's disease or ulcerative colitis
  • Has had a colectomy
  • Has a 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 history of lower GI bleeding
  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has cirrhosis
  • Has heart failure
  • Has dementia
  • Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Treatment and study plan

Opt-In Outreach

Behavioral

Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to elect to receive a home FIT kit or report prior screening.

Opt-Out Outreach

Behavioral

Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to choose not to receive a home FIT kit or report prior screening. A FIT kit will otherwise be sent to the subject as a default.

Primary outcomes

  1. FIT Completion Rate

    Time frame: 3 months

    The percentage of participants who successfully complete the FIT.

Secondary outcomes

  1. Mail/Electronic Message Engagement

    Time frame: 3 months

    The percentage of people who send responses using either mail or electronic messaging.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 11, 2016
Registry last updated
May 26, 2020

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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