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Completed

NCT Number: NCT04711473

Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health and Dental Care

Pottstown, Pennsylvania, 19465, United States

About this study

The investigators will evaluate the effectiveness of mailed outreach with choice between colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC screening rates.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 1 visit with CHDC in the past 2 years
  • Not up to date on CRC screening (no evidence of colonoscopy in the last 10 years, sigmoidoscopy in the last 5 years, or stool testing in the past 12 months)

Exclusion criteria

  • History of CRC or polyps
  • Significant family history of CRC
  • History of Inflammatory Bowel Disease or Ulcerative Colitis
  • History of colectomy
  • History of metastatic cancer
  • Current use of Medication Assisted Therapy (MAT)

Treatment and study plan

Colonoscopy only

Behavioral

Mailed letter asking participants to complete CRC screening by colonoscopy

Choice

Behavioral

Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT

FIT Only

Behavioral

Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT

Primary outcomes

  1. Colorectal Cancer Screening Completion

    Time frame: 6 months from initial outreach

    Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately.

Secondary outcomes

  1. Choice of Colorectal Cancer Screening Test

    Time frame: 6 months from initial outreach

    The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice)

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Jan 13, 2023

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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