Impact of SMS Messaging on Participation in Colorectal Cancer Screening.

Corporacion Parc Tauli10,084 enrolled

Overview

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.

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

Interventions

Text MessagingBEHAVIORAL

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).

Standard invitation and postal reminder lettersBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Participation rate

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.

Time frame: 3 and 6 months after the initial invitation.

Secondary Outcomes

Time to participation

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 ).

Time frame: 3 and 6 months after the initial invitation (at the conclusion of the study follow-up).

Number of reminder letters sent

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.

Time frame: 3 and 6months after the initial invitation.