Colorectal CancerNCT05004376
Text-based Colorectal Cancer Prevention Pilot
A study testing Text Messaging in people with Colorectal Cancer, run by University of Rochester at 1 site in United States.
Trial summary
In this project, we intend to conduct a randomized pilot trial of a structured behavioral intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening recommendations. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 1 Jun 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Present at Strong Memorial Hospital or Noyes Community Hospital Emergency Departments
- Age 45-75
- English or Spanish speaking
- Capacity to consent
Who cannot join
- Personal and/or family history of colorectal cancer
- Personal history of inflammatory bowel disease
- History of abdominal or pelvic radiation to treat a prior cancer
- Non-English and Non-Spanish speaking
- Inability to consent
- Lack of text-capable mobile phone and/or inability to use text function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Text-based Intervention to Improve Adherence to Colorectal Cancer Screening Recommendations Among Emergency Department Patients
In this project, we intend to conduct a randomized pilot trial of a structured behavioral intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening recommendations. We will also collect qualitative feedback on perceptions of the intervention to inform its refinement.
Read the detailed description
The investigators propose a pilot randomized controlled trial with a prospectively collected convenience sample of 130 ED patients non-adherent with CRC screening guidelines over a 3-month period. ED Research Associates (EDRAs) will use the EPIC eRecord system to screen adult patients registered in the ED at URMC and Noyes Memorial Hospital (when an EDRA is present in that ED) for eligibility. Inclusion criteria will include: 45-75 years and English or Spanish speaking (costs for interpreting study surveys and patient interactions will be paid for from PI discretionary research funds). Exclusion criteria will include personal and/or family history of colorectal cancer, personal history of inflammatory bowel disease, and a history of abdominal or pelvic radiation to treat a prior cancer. These exclusions were chosen due to their impact on standard colorectal screening recommendations. After consent, subjects will complete a ~10-minute questionnaire administered by the EDRA to determine adherence to current USPSTF guidelines for colorectal cancer screening using validated items in the CDC's National Health Interview Survey16. The enrollment process will categorize study participants into three groups: adherent, uncertain, or non-adherent. Subjects found to be adherent will be notified and their participation will conclude. Subjects found to be in the uncertain or non-adherent groups will be randomized into the treatment or control condition. Following intervention, subjects who were non-adherent will be referred to their usual care provider to discuss options for becoming adherent. Subjects for whom adherence is uncertain will be referred to their usual care provider to confirm their adherence status. Subjects who find through their PCP that they are adherent will be treated as screen failures. Sensitivity analyses will be performed to evaluate estimates of intervention efficacy with and without inclusion of subjects initially determined uncertain and later categorized as non-adherent. Following the initial enrollment, randomization, and recommendation to contact their PCPs, subjects in the intervention condition will receive a series of 6 text messages, sent at approximately 15 day intervals, presenting theory-based messages aimed at encouraging colorectal cancer screening uptake. Subjects without a primary care provider will be given information on how to establish a PCP in Rochester and on cancer screening services subsidized through the Cancer Services Program (CSP) of the Finger Lakes Region (our current R01 includes referrals to the CSP). All subjects in the non-adherent and uncertain groups will receive a follow-up call at 150 days for a ~5-minute survey to determine if they underwent or scheduled screening, if they learned that they did not require screening, and what barriers they perceived in getting screened. Qualitative feedback regarding perceptions of the intervention will also be collected in order to refine the intervention for future study. Medical chart review will also be conducted to confirm patient self-reports, making use of UR records and records from the Rochester Regional Health Information Organization (RHIO; our current R01 has incorporated the RHIO).Completion of a "second-level" consent form for use of the RHIO for chart review will be required for enrollment. In our cervical cancer pilot study, we successfully contacted 68% of participants for follow-up, 11 of whom declined to complete the follow-up interview. Based on lessons learned in our preliminary work, we have developed several strategies (currently employed in our R01 study), in addition to the incentive payment for study completion, which we will employ to maximize retention in this study:
- Telephone numbers will be confirmed in the ED during enrollment by the EDRA performing the enrollment by calling the patient's phone to be certain the number is correct.
- Up to five calls will be made to each study participant during the follow-up window.
- Each participant will be provided with study team contact information and asked to notify us in the event that their phone number changes.
- In addition to their primary cell phone number, alternative contact information will be sought from each participant to enable attempts at re-engagement, including: a.Secondary telephone number of participant b.Email address(es) and mailing address.
- The EHR will be accessed to check for changes in contact information
- Conditions
- Colorectal Cancer
- Being tested
- Text Messaging
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
Text messages based on behavioral theory to encourage scheduling colorectal cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Non-adherent control | No intervention | Control subjects will receive no text intervention and a 150 day follow-up phone call. |
| Non-adherent intervention | Experimental | Intervention subjects will receive the text messaging intervention and a 150 day follow-up phone call. Receives: Behavioral: Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening
Rates of completed or scheduled screening
Measured: 150 days
Secondary outcomes (1)
Phone Interview for refinement of Intervention
Collect qualitative feedback on perceptions of the intervention to inform its refinement.
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start3 Jan 2022
- Primary completion31 May 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with a prospectively collected convenience sample
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beau Abar, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004376
- Sponsor's protocol ID
- 00006479
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abar B, Park CS, Wood N, Marino D, Fiscella K, Adler D. Intervention to increase colorectal cancer screening among emergency department patients: results from a randomised pilot study. Emerg Med J. 2024 Jun 20;41(7):422-428. doi: 10.1136/emermed-2023-213761.
PubMed 38777559
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text-based Intervention to Improve Adherence to Colorectal Cancer Screening Recommendations Among Emergency Department Patients
- ClinicalTrials.gov ID
- NCT05004376
- Acronym / sponsor ID
- 00006479
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 Aug 2021 (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 this project, we intend to conduct a randomized pilot trial of a structured behavioral intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening recommendations. We will also collect qualitative feedback on perceptions of the intervention to inform its refinement.
Detailed description
The investigators propose a pilot randomized controlled trial with a prospectively collected convenience sample of 130 ED patients non-adherent with CRC screening guidelines over a 3-month period. ED Research Associates (EDRAs) will use the EPIC eRecord system to screen adult patients registered in the ED at URMC and Noyes Memorial Hospital (when an EDRA is present in that ED) for eligibility. Inclusion criteria will include: 45-75 years and English or Spanish speaking (costs for interpreting study surveys and patient interactions will be paid for from PI discretionary research funds). Exclusion criteria will include personal and/or family history of colorectal cancer, personal history of inflammatory bowel disease, and a history of abdominal or pelvic radiation to treat a prior cancer. These exclusions were chosen due to their impact on standard colorectal screening recommendations. After consent, subjects will complete a ~10-minute questionnaire administered by the EDRA to determine adherence to current USPSTF guidelines for colorectal cancer screening using validated items in the CDC's National Health Interview Survey16. The enrollment process will categorize study participants into three groups: adherent, uncertain, or non-adherent. Subjects found to be adherent will be notified and their participation will conclude. Subjects found to be in the uncertain or non-adherent groups will be randomized into the treatment or control condition. Following intervention, subjects who were non-adherent will be referred to their usual care provider to discuss options for becoming adherent. Subjects for whom adherence is uncertain will be referred to their usual care provider to confirm their adherence status. Subjects who find through their PCP that they are adherent will be treated as screen failures. Sensitivity analyses will be performed to evaluate estimates of intervention efficacy with and without inclusion of subjects initially determined uncertain and later categorized as non-adherent. Following the initial enrollment, randomization, and recommendation to contact their PCPs, subjects in the intervention condition will receive a series of 6 text messages, sent at approximately 15 day intervals, presenting theory-based messages aimed at encouraging colorectal cancer screening uptake. Subjects without a primary care provider will be given information on how to establish a PCP in Rochester and on cancer screening services subsidized through the Cancer Services Program (CSP) of the Finger Lakes Region (our current R01 includes referrals to the CSP). All subjects in the non-adherent and uncertain groups will receive a follow-up call at 150 days for a ~5-minute survey to determine if they underwent or scheduled screening, if they learned that they did not require screening, and what barriers they perceived in getting screened. Qualitative feedback regarding perceptions of the intervention will also be collected in order to refine the intervention for future study. Medical chart review will also be conducted to confirm patient self-reports, making use of UR records and records from the Rochester Regional Health Information Organization (RHIO; our current R01 has incorporated the RHIO).Completion of a "second-level" consent form for use of the RHIO for chart review will be required for enrollment. In our cervical cancer pilot study, we successfully contacted 68% of participants for follow-up, 11 of whom declined to complete the follow-up interview. Based on lessons learned in our preliminary work, we have developed several strategies (currently employed in our R01 study), in addition to the incentive payment for study completion, which we will employ to maximize retention in this study:
- Telephone numbers will be confirmed in the ED during enrollment by the EDRA performing the enrollment by calling the patient's phone to be certain the number is correct.
- Up to five calls will be made to each study participant during the follow-up window.
- Each participant will be provided with study team contact information and asked to notify us in the event that their phone number changes.
- In addition to their primary cell phone number, alternative contact information will be sought from each participant to enable attempts at re-engagement, including: a.Secondary telephone number of participant b.Email address(es) and mailing address.
- The EHR will be accessed to check for changes in contact information
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with a prospectively collected convenience sample
| Arm | Type | Receives |
|---|---|---|
| Non-adherent control | No intervention | –Control subjects will receive no text intervention and a 150 day follow-up phone call. |
| Non-adherent intervention | Experimental | Behavioral: Text MessagingIntervention subjects will receive the text messaging intervention and a 150 day follow-up phone call. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Present at Strong Memorial Hospital or Noyes Community Hospital Emergency Departments
- Age 45-75
- English or Spanish speaking
- Capacity to consent
Key exclusion criteria (6 listed)
- Personal and/or family history of colorectal cancer
- Personal history of inflammatory bowel disease
- History of abdominal or pelvic radiation to treat a prior cancer
- Non-English and Non-Spanish speaking
- Inability to consent
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 |
|---|---|---|
| Text MessagingText messages based on behavioral theory to encourage scheduling colorectal cancer screening. | Behavioural | Non-adherent intervention |
Primary outcome
Screening
Time frame: 150 days
Rates of completed or scheduled screening
1 secondary outcome
Phone Interview for refinement of Intervention
Time frame: 150 days
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 14 Jul 2023.
- Derived from this study: PubMed 38777559Abar B, Park CS, Wood N, Marino D, Fiscella K, Adler D. Intervention to increase colorectal cancer screening among emergency department patients: results from a randomised pilot study. Emerg Med J. 2024 Jun 20;41(7):422-428. doi: 10.1136/emermed-2023-213761.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging in people with Colorectal Cancer, run by University of Rochester at 1 site 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 6 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Screening (time frame: 150 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004376, which also lists 1 linked publication.
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 14 Jul 2023.