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

NCT ID: NCT04711473

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2022-11-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Colonoscopy Only

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in colonoscopy, and including a referral for the procedure at a local endoscopy center. Participants will be provided a phone number if interested in navigated colonoscopy scheduling.

Group Type ACTIVE_COMPARATOR

Colonoscopy Only

Intervention Type BEHAVIORAL

Mailed letter asking participants to complete CRC screening by colonoscopy

Choice

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in their choice of either colonoscopy or mailed fecal immunochemical testing (FIT). The letter will include both a referral for the colonoscopy at a local endoscopy enter and a FIT kit with a lab requisition and instructions for completion.

Group Type EXPERIMENTAL

Choice

Intervention Type BEHAVIORAL

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

FIT Only

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in FIT testing. The letter will include a FIT kit with lab requisition and instructions for completion.

Group Type EXPERIMENTAL

FIT Only

Intervention Type BEHAVIORAL

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

Interventions

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Colonoscopy Only

Mailed letter asking participants to complete CRC screening by colonoscopy

Intervention Type BEHAVIORAL

Choice

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

Intervention Type BEHAVIORAL

FIT Only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. At least 1 visit with CHDC in the past 2 years
2. 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

1. History of CRC or polyps
2. Significant family history of CRC
3. History of Inflammatory Bowel Disease or Ulcerative Colitis
4. History of colectomy
5. History of metastatic cancer
6. Current use of Medication Assisted Therapy (MAT)
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shivan Mehta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Community Health and Dental Care

Pottstown, Pennsylvania, United States

Site Status

Countries

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United States

References

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Mehta SJ, Palat S, McDonald C, Reitz C, Okorie E, Williams K, Tao J, Shaw PA, Glanz K, Asch DA. A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2117-2124.e2. doi: 10.1016/j.cgh.2024.04.003. Epub 2024 Apr 30.

Reference Type DERIVED
PMID: 38697235 (View on PubMed)

Other Identifiers

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843772

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 13220

Identifier Type: -

Identifier Source: org_study_id

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