Impact of SMS Messaging on Participation in Colorectal Cancer Screening.

June 1, 2026 updated by: Anna Selva, Corporacion Parc Tauli

Impact of SMS Notifications on the Colorectal Cancer Screening Program.

Colorectal cancer is a leading cause of mortality in Catalonia. Although early detection programs using the fecal immunochemical test (FIT) are effective in reducing both incidence and mortality, their success relies on high population participation. Currently, in the Vallès Occidental region, the participation rate stands at 42%, which is below the 65% minimum recommended by European health authorities.

The objective of this randomized controlled trial is to evaluate whether sending a reminder text message (SMS) is an effective tool to increase participation in the screening program. The study will include 10,084 participants aged between 50 and 69 years. Half of the participants will receive a reminder SMS five weeks after their initial invitation, while the other half will follow the standard of care involving postal letters. Researchers anticipate that this strategy will not only increase the number of individuals undergoing screening but also shorten the response time and reduce the need for sending postal reminders.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a randomized, controlled, parallel-group clinical trial with a 1:1 allocation ratio. It will be conducted within the framework of the Colorectal Cancer Early Detection Program (PDPCCR) of the Vallès Occidental region, coordinated by the Cancer Screening Unit of the Consorci Corporació Sanitària Parc Taulí.

Procedure and Timeline:

Week 0: All individuals in the target population (aged 50-69 years) receive a standard invitation letter.

Week 5: Individuals who have not yet participated are randomized using a computer-generated sequence. The Intervention Group receives a reminder SMS.

Week 6: Non-participants from both the control and the intervention groups receive the standard postal reminder letter.

Follow-up: Final participation will be evaluated at two time points: at 3 and 6 months after the initial invitation.

Variables and Analysis:

Primary Outcome: participation rate, defined as the proportion of individuals who complete a valid fecal immunochemical test (FIT) from those elegible.

Secondary Outcomes: time to participation (measured in days) and number of postal reminder letters sent.

Statistical Analysis: Descriptive analysis with N, proportions, medians and 25-75 percentiles. Bivariate analysis: Chi-square tests to compare participation between groups and the Mann-Whitney U test for response time. Relative risks will be calculated. Multivariate analysis: a binary logistic regression will be performed to adjust results for variables such as sex, age, and previous participation. The analysis will be conducted on both an intent-to-treat (ITT) and per-protocol basis.

Study Type

Interventional

Enrollment (Estimated)

10084

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anna Selva Olid, PhD
  • Phone Number: 82240 +34937231010
  • Email: aselva@tauli.cat

Study Contact Backup

  • Name: Marina Lleal Custey, PhD
  • Phone Number: 82241 +34937231010
  • Email: mlleal@tauli.cat

Study Locations

  • Spain
    • Catalonia
      • Sabadell, Catalonia, Spain, 08208
        • Recruiting
        • Unitat de Cribratge de Cáncer, Consorci Corporació Sanitaria Parc Taulí
        • Contact:
        • Contact:
          • Marina Lleal Custey, PhD
          • Phone Number: 82239 +34937231010
          • Email: mlleal@tauli.cat
        • Principal Investigator:
          • Anna Selva Olid, PhD
        • Principal Investigator:
          • Marina Lleal Custey, PhD
        • Sub-Investigator:
          • Cessia Vilcahuamán Esteban, RN, Sp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women and men aged 50 to 69 years.
  • Residents of the Vallès Occidental area.
  • Individuals invited to the Colorectal Cancer Screening Program (PDPCCR) who have not participated within 5 weeks of the initial invitation.

Exclusion Criteria:

  • Personal history of colorectal cancer.
  • Inflammatory bowel disease (IBD)
  • Colorectal polyps requiring specific clinical follow-up.
  • Hereditary polyposis syndromes.
  • High-risk family history of colorectal cancer: a first-degree relative diagnosed before age 50, or two or more first-degree relatives at any age.
  • Severe morbidity that precludes the performance of a colonoscopy in the event of a positive test result.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group: Standard Care
Participants in this group follow the screening program's standard operating procedure. This consists of an initial invitation letter sent at week 0 and, in the event of non-participation, a postal reminder letter sent at week 6.
Behavioral: Standard invitation and postal reminder letters

Control intervention based on the colorectal cancer screening program's usual standard of care. Components and Timing:

  1. Delivery of a nominal invitation letter at week 0, including program information and instructions for collecting the fecal immunochemical test (FIT) kit at community pharmacies.
  2. In the event of non-participation, delivery of a physical postal reminder letter at week 6.

Duration: Participation follow-up for both components concludes 3 months after the initial invitation. This study arm receives no digital or telephone-based stimuli during the study period.
Experimental: Intervention Group: SMS + Standard Care
Participants receive the initial invitation letter at week 0. If they have not participated by week 5, a reminder text message (SMS) is sent. If they remain non-responsive following the SMS, they receive the standard postal reminder letter at week 6.
Behavioral: Standard invitation and postal reminder letters

Control intervention based on the colorectal cancer screening program's usual standard of care. Components and Timing:

  1. Delivery of a nominal invitation letter at week 0, including program information and instructions for collecting the fecal immunochemical test (FIT) kit at community pharmacies.
  2. In the event of non-participation, delivery of a physical postal reminder letter at week 6.

Duration: Participation follow-up for both components concludes 3 months after the initial invitation. This study arm receives no digital or telephone-based stimuli during the study period.

Behavioral: Text Messaging
Behavioral intervention consisting of a one-way text message (SMS) sent to the mobile phones of participants who have not completed the fecal immunochemical test (FIT) following the initial invitation. Frequency and Timing: A single SMS is sent exactly 5 weeks after the issuance of the standard invitation letter, one week prior to the scheduled postal reminder. Platform: The delivery is centrally managed through the secure 'Alhora' platform. The message was previously validated through a qualitative pilot study to ensure readability and acceptability by the target population (aged 50-69).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rate
Time Frame: 3 and 6 months after the initial invitation.
Proportion of individuals who complete a valid fecal immunochemical test (FIT) relative to the total number of individuals invited. This variable will be objectively obtained through the screening program's information system.
3 and 6 months after the initial invitation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to participation
Time Frame: 3 and 6 months after the initial invitation (at the conclusion of the study follow-up).
Measurement of the number of days elapsed from the delivery of the initial invitation letter to the effective completion of the test (defined as the moment the participant's sample is analyzed in the laboratory ).
3 and 6 months after the initial invitation (at the conclusion of the study follow-up).
Number of reminder letters sent
Time Frame: 3 and 6months after the initial invitation.
Total count of postal reminder letters sent by the program for participants in each group. This measure evaluates whether the SMS in the intervention group reduces the need for paper-based reminders.
3 and 6months after the initial invitation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Collaborators

Universitat Autonoma de Barcelona

Investigators

  • Principal Investigator: Anna Selva Olid, PhD, MPH, MD, Corporación Parc Taulí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026.054-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Restricted Access and Security: The protocol stipulates that data will be stored on secure hospital servers with access strictly limited to authorized research staff through encryption systems and secure passwords.

Privacy and Confidentiality: The use of personal identifying data is strictly limited to the technical execution of the intervention (SMS delivery). The research team has implemented measures to ensure the anonymization of the analytical database.

Legal Compliance: The study is governed by Regulation (EU) 2016/679 (GDPR) and Organic Law 3/2018 on the Protection of Personal Data, which imposes legal restrictions on the transfer of individual data outside the consented framework for this specific research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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