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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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)
- 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.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- 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 group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | This 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" | Experimental | This group will receive an SMS text message highlighting their risk for CRC. Receives: Behavioral: Risk Information |
| "Risk Information + Action" | Experimental | This 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.
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)
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
CRC45+ Choice MyChart Message opened
Rate of opening MyChart message
Measured: 1 month after getting the initial text message
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.
- First posted16 Mar 2022
- Study start21 Feb 2022
- Primary completion21 Aug 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- UCLA Vatche and Tamar Manoukian Division of Digestive Diseases, Carnegie Mellon University
- Responsible party
- Principal investigator, Daniel M. Croymans, MD, MBA, MS, University of California, Los Angeles
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement Study Aimed at Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49 (CRC45+ TEXT).
- ClinicalTrials.gov ID
- NCT05281159
- Acronym / sponsor ID
- CRC45+TEXT / CRC45+TEXT
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Keywords
- Colorectal Cancer Screening, Behavioral Economics, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,509 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- UCLA Vatche and Tamar Manoukian Division of Digestive Diseases, Carnegie Mellon University
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 21 Aug 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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)
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –This 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" | Experimental | Behavioral: Risk InformationThis group will receive an SMS text message highlighting their risk for CRC. |
| "Risk Information + Action" | Experimental | Behavioral: Risk Information + ActionThis group will receive an SMS message highlighting their risk for CRC and the importance of taking quick action. |
Who may qualify
- Ages
- 45 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- UCLA Health patient
- Age 45-49 (as of 2/1/2022)
- Active primary care provider
- Visit within the last 3 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk InformationThis group will receive an SMS text message highlighting their risk for CRC on top of the content in the Control arm. | Behavioural | "Risk Information" |
| Risk Information + ActionThis 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. | Behavioural | "Risk Information + Action" |
Primary outcome
Opening link within SMS Text message
Time frame: 1 week after getting the initial text message
Rate of clicking the link to MyChart within the SMS text message
3 secondary outcomes
Opening link within SMS Text Message
Time frame: 1 month after getting initial text message
CRC45+ Choice MyChart Message opened
Time frame: 1 month after getting the initial text message
Overall completion of any CRC screening test
Time frame: 6 months after getting the initial text message
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.