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OpenTrials
Completed

NCT Number: NCT03246438

Choice Architecture and Colorectal Cancer Screening Outreach

This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

About this study

This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms:

Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

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 a primary care provider who is a University City or Valley Forge Family Medicine provider
  • Has had at least 2 office visits at either practice
  • Is due for colorectal cancer screening
  • Is asymptomatic for CRC
  • Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area

Exclusion criteria

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures)
  • Has a history of CRC or colonic polyps
  • Has a history of GI cancer
  • Has a history of confirmed Inflammatory Bowel Disease (IBD)
  • has a history of colitis other than Crohns disease or ulcerative colitis)
  • Has a first degree relative that has been diagnosed with CRC
  • Has had a colectomy
  • Has been diagnosed with Familial Adenomatous Polyposis (FAP)
  • Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  • Has iron-deficiency anemia
  • Has a 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

Colonoscopy only

Behavioral

Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.

Other names: Control

Colonoscopy outreach + mailed FIT follow-up

Behavioral

Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.

Other names: Sequential Choice

Colonoscopy + Mailed FIT outreach and follow-up

Behavioral

Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.

Other names: Active Choice

Primary outcomes

  1. CRC screening completion

    Time frame: 4 months

    The percentage of participants who successfully complete FIT or colonoscopy

Secondary outcomes

  1. Choice of screening test

    Time frame: 4 months

    The percentage of participants who choose either screening method (FIT vs. colonoscopy)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Choice Architecture and Mailed Outreach for Colorectal Cancer Screening

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 11, 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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