NCT05275530

Brief Summary

In May of 2021, the United States Preventive Service Task Force (USPSTF) updated their colorectal cancer (CRC) screening guidelines by recommending screening at an earlier age for average-risk adults starting at the age of 45 years old (Grade B recommendation). This is in addition to their Grade A recommendations of continuing to screen average-risk adults ages 50-75 years old. UCLA Health previously implemented a fecal immunochemical test (FIT) outreach program wherein FIT kits are mailed to average-risk patients overdue for CRC screening twice annually to promote screening uptake. As the investigators health system aims to screen the newly eligible population of average-risk patients between the ages of 45-49, the investigators proposed randomized controlled trial is aimed to determine the most effective patient outreach approach to maximize screening uptake within this age-group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,509

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

February 19, 2022

Last Update Submit

November 9, 2023

Conditions

Keywords

Colorectal Cancer ScreeningChoice

Outcome Measures

Primary Outcomes (1)

  • Overall completion of any Colorectal Cancer Screening test

    Rate of completion of any CRC screening (FIT Kit or Colonoscopy) throughout the observation window.

    6 months after getting the text message

Secondary Outcomes (3)

  • Selection of modality in MyChart Survey

    within 4 weeks from receiving the initial MyChart message

  • CRC screening order placed by any modality

    within 6 weeks from receiving the initial MyChart message

  • Colorectal cancer screening uptake by modality

    6 months after getting the initial MyChart message

Study Arms (4)

Standard of Care

NO INTERVENTION

No Intervention-"Standard Care" UCLA Health has a mailed FIT outreach program. This group will receive standard FIT mailer protocol. They will receive a tailored MyChart message indicating the importance of CRC screening and not be presented with a choice for screening modalities.

FIT Choice

EXPERIMENTAL

This group will receive a tailored message via MyChart with information about CRC screening and using the FIT kit for noninvasive screening. They will then have to actively choose if they want CRC screening with a FIT kit vs no screening. If they opt for screening, the investigators will mail them a FIT kit.

Behavioral: Active FIT Choice

Colonoscopy Choice

EXPERIMENTAL

This group will receive a tailored message via MyChart with information about CRC screening and colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a colonoscopy vs no screening. If they opt for screening, the investigators will direct them to our patient navigators to get scheduled for a colonoscopy.

Behavioral: Active Colonoscopy Choice

Dual Choice

EXPERIMENTAL

This group will receive a tailored message via MyChart with information about CRC screening and using either the FIT kit or colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a FIT kit, a colonoscopy, or no screening. If they opt for screening, the investigators will either mail them a FIT kit or direct them to our patient navigators to schedule a colonoscopy, depending on their choice.

Behavioral: Active Dual Choice

Interventions

The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about FIT as a screening strategy. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with a FIT, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices.

FIT Choice

The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about colonoscopy as a screening strategy. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with a colonoscopy, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices.

Colonoscopy Choice

The investigators will send randomized participants a message via MyChart indicating the benefits of CRC screening, along with tailored information about FIT Kit and Colonoscopy screening. At the end of the message, participants will complete a survey asking them to indicate if they would like to be screened for CRC with either a FIT or Colonoscopy, or if they prefer no screening whatsoever. The investigators will then ask follow-up questions to better understand the reason patients made their respective choices.

Dual Choice

Eligibility Criteria

Age45 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • UCLA Health patient
  • Age 45-49 (as of 1/1/2022)
  • Active primary care provider at UCLA Health
  • Visit within the last 3 years

You may not qualify if:

  • Age \<45 or \>50 years old at time of randomization
  • Documented family history of CRC in EMR
  • History (personal or family) of prior adenomatous polyps in the EHR
  • History of high-risk cancer syndromes (e.g., Lynch, FAP)
  • Prior CRC screening with colonoscopy or FIT
  • Inactive MyChart status at enrollment
  • No documented SMS-capable phone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Health Department of Medicine, Quality Office

Los Angeles, California, 90095, United States

Location

UCLA Vatche and Tamar Manoukian Division of Digestive Diseases

Westwood, Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Galoosian A, Dai H, Croymans D, Saccardo S, Fox CR, Goshgarian G, De Silva S, Han MA, Vangala S, May FP. Population Health Colorectal Cancer Screening Strategies in Adults Aged 45 to 49 Years: A Randomized Clinical Trial. JAMA. 2025 Sep 2;334(9):778-787. doi: 10.1001/jama.2025.12049.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: * Parallel-arm randomized controlled trial * Patient-level randomization * Four arms * Arm 0: Standard of care control * Arm 1: Active FIT choice * Arm 2: Active colonoscopy choice * Arm 3: Active FIT v. colonoscopy choice
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, DOM Quality

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 11, 2022

Study Start

February 21, 2022

Primary Completion

August 21, 2022

Study Completion

November 21, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

We do not plan to make any individual participant data available.

Locations