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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.

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 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
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.

United States1 site
  • Strong Hospital

    Rochester, New York, 14642

Other trials in United States

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:

  1. 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.
  2. Up to five calls will be made to each study participant during the follow-up window.
  3. Each participant will be provided with study team contact information and asked to notify us in the event that their phone number changes.
  4. 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.
  5. The EHR will be accessed to check for changes in contact information
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 groups in NCT05004376
Study groupRoleWhat they receive
Non-adherent controlNo interventionControl subjects will receive no text intervention and a 150 day follow-up phone call.
Non-adherent interventionExperimentalIntervention 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.

  1. Screening

    Rates of completed or scheduled screening

    Measured: 150 days

Secondary outcomes (1)
  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.

  1. First posted13 Aug 2021
  2. Study start3 Jan 2022
  3. Primary completion31 May 2022
  4. Study completion1 Jun 2023

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
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)
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

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.

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Text-based Colorectal Cancer Prevention Pilot | AzTrials