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Colorectal CancerCRC45+TEXTNCT05281159

Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49

A study testing Risk Information and Risk Information + Action in people with Colorectal Cancer and Colorectal Neoplasms, run by University of California, Los Angeles at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer, Colorectal Neoplasms
What is being tested?
Risk Information and Risk Information + Action
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20,509 participants
Where
2 sitesUnited States
Study dates
21 Feb 2022to 21 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • UCLA Health patient
  • Age 45-49 (as of 2/1/2022)
  • Active primary care provider
  • Visit within the last 3 years

Who cannot join

  • 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 EMR
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • UCLA Health Department of Medicine, Quality Office

    Westwood, Los Angeles, California, 90095

  • UCLA Vatche and Tamar Manoukian Division of Digestive Diseases

    Westwood, Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Quality Improvement Study Aimed at Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49 (CRC45+ TEXT).

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. 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 increase patients' engagement with messages regarding CRC screening and screening uptake within this specific age-group.

Read the detailed description

Colorectal cancer (CRC) is the second leading cause of cancer-related death for both men and women in the United States. One in 17 Americans will suffer from CRC during their lifetime and early detection of cancers and polyps by screening is shown to reduce CRC mortality. In 2021, the USPSTF updated its CRC screening guidelines to start screening average-risk individuals at the age of 45 years due in part to a rising incidence of CRC and premalignant polyps in younger patients.

This current study will be a nested study within a larger investigation to determine the most effective patient outreach approach to increase patients' engagement with messages regarding CRC screening and CRC screening utilization in average-risk individuals ages 45-49 years. Here the investigators are testing which type of SMS messaging is most effective in prompting people to review MyChart message regarding CRC screening and thus increasing CRC screening uptake among individuals 45-49 years old.

There will be three different text messages that have been formulated utilizing behavioral science principles, and then randomize them equally among the eligible population. There will be stratified patient randomization based on arm assignment in our 'CRC45+ Choice' evaluation to prevent cross-study contamination. The arms for this investigation will be 1) Control, 2) Risk Information and 3) Risk Information + Action. In the control (standard care) arm, patients will receive the standard SMS text message. In the Risk Information arm, patients will receive a message indicating their risk for colorectal cancer, on top of the content in the Control arm. Finally, in the Risk Information + Action arm patients will receive risk information and importance of taking quick action, on top of the content in the Control arm. The investigators will also randomly assign patients into receiving our text message on one of ten workdays, stratifying by arm assignment in both the CRC45+ Choice Evaluation and CRC45+ Text Evaluation.

We will send text reminders to patients two weeks after they receive the initial text message. Reminder content will be very similar to the content of initial text message, and differ by arm.

For this investigation the investigators hypothesize:

  1. Hyp 1: Patients assigned to the Risk Information + Action Arm (Arm 2) will have a higher click rate than patients assigned to the Control Arm (Arm 0)
  2. Hyp 2: Patients assigned to the Risk Information + Action Arm (Arm 2) will have a higher click rate than patients assigned to the Risk Information Arm (Arm 1)

Analysis: The investigators will utilize patient-level ordinary least squares (OLS) estimation, with statistical inferences based on model-robust standard errors. The primary model term will be indicator variables for arm assignment.

The analysis will adjust for sex, race/ethnicity, social vulnerability index (at the ZIP code level), and MyChart logins decile.

Treatment effects will be summarized using rate differences and 95% CI's. Exploratory analyses will investigate heterogenous treatment effects by demographic subgroups by splitting the sample into each demographic subgroup as well as by testing demographics and text message arm interactions. Sensitivity analyses will be performed without covariates, and using logistic regression models in place of linear regression models. Missing covariate values will be handled by including 'unknown' indicators, along with mean imputation for quantitative covariates.

The investigators will additionally explore how click rates within the SMS message vary with the day of the week.

Primary analyses will use intention-to-treat protocol.

Being tested
Risk Information, Risk Information + Action
Keywords
Colorectal Cancer Screening, Behavioral Economics, Colorectal Cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk InformationBehavioural

    This group will receive an SMS text message highlighting their risk for CRC on top of the content in the Control arm.

  • Risk Information + ActionBehavioural

    This group will receive an SMS text message highlighting their risk for CRC and the importance of taking quick action, on top of the content in the Control arm.

Study groups in NCT05281159
Study groupRoleWhat they receive
Standard of CareNo interventionThis group will receive a standard SMS text message indicating that they have a MyChart message from their provider about CRC screening and should follow a link to be screened.
"Risk Information"ExperimentalThis group will receive an SMS text message highlighting their risk for CRC.
Receives: Behavioral: Risk Information
"Risk Information + Action"ExperimentalThis group will receive an SMS message highlighting their risk for CRC and the importance of taking quick action.
Receives: Behavioral: Risk Information + Action

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opening link within SMS Text message

    Rate of clicking the link to MyChart within the SMS text message

    Measured: 1 week after getting the initial text message

Secondary outcomes (3)
  1. Opening link within SMS Text Message

    Rate of clicking the link to MyChart within the SMS text message during 1 month

    Measured: 1 month after getting initial text message

  2. CRC45+ Choice MyChart Message opened

    Rate of opening MyChart message

    Measured: 1 month after getting the initial text message

  3. Overall completion of any CRC screening test

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

    Measured: 6 months after getting the initial text message

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start21 Feb 2022
  3. Primary completion21 Aug 2022
  4. Study completion21 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment * Parallel-arm randomized controlled trial, * Three arms * Arm 0: Standard of care control (standard text messaging) * Arm 1: Experimental, "Risk Information" group * Arm 2: Experimental, "Risk Information + Action" group * Patient-level randomization stratified by arm assignment in CRC45+ Choice Evaluation. The investigators will also randomly assign patients into receiving the text message on one of ten workdays, stratifying by arm assignment in both the CRC45+ Choice Evaluation and CRC45+ Text Evaluation
Masking
None (open label)
Enrolment
20,509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05281159
Sponsor's protocol ID
CRC45+TEXT
Acronym
CRC45+TEXT
Status last verified
Nov 2023
First submitted
27 Feb 2022
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Risk Information and Risk Information + Action in people with Colorectal Cancer and Colorectal Neoplasms, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opening link within SMS Text message (time frame: 1 week after getting the initial text message). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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