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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04711473

Enrollment

800

Registered

2021-01-15

Start date

2021-10-27

Completion date

2022-11-11

Last updated

2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

screening, prevention, colonoscopy, stool testing

Brief summary

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

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.

Interventions

BEHAVIORALColonoscopy Only

Mailed letter asking participants to complete CRC screening by colonoscopy

BEHAVIORALChoice

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

BEHAVIORALFIT Only

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 74 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Colorectal Cancer Screening Completion	6 months from initial outreach	Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately.

Secondary

Measure	Time frame	Description
Choice of Colorectal Cancer Screening Test	6 months from initial outreach	The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026