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Choice Architecture and Colorectal Cancer Screening Outreach

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University of Pennsylvania

Status

Completed

Conditions

Cancer of Colon

Treatments

Behavioral: Colonoscopy + Mailed FIT outreach and follow-up
Behavioral: Colonoscopy outreach + mailed FIT follow-up
Behavioral: Colonoscopy only

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full description

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).

Enrollment

423 patients

Sex

All

Ages

50 to 74 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

423 participants in 3 patient groups

Control
Experimental group
Description:
Colonoscopy only outreach and follow-up
Treatment:
Behavioral: Colonoscopy only
Sequential Choice
Experimental group
Description:
Colonoscopy outreach + mailed FIT follow-up
Treatment:
Behavioral: Colonoscopy outreach + mailed FIT follow-up
Active Choice
Experimental group
Description:
Colonoscopy + mailed FIT outreach and follow-up
Treatment:
Behavioral: Colonoscopy + Mailed FIT outreach and follow-up

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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