An interventional study of Text Messaging and Standard invitation and postal reminder letters in Colorectal Neoplasms and Early Detection of Cancer, sponsored by Corporacion Parc Tauli. Recruiting at 1 site in Spain. Open to participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Health services research
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 a pragmatic, randomized, parallel-group clinical trial with a 1:1 allocation ratio, conducted within the framework of the Colorectal Cancer Early Detection Program (PDPCCR) in the Vallès Occidental region. The trial is coordinated by the Cancer Screening Unit of the Consorci Corporació Sanitària Parc Taulí.
Operational Flow and Randomization: The study follows a sequential recruitment process. At Week 0, the entire target population receives a standard invitation letter according to the program's usual standard of care. For individuals who have not participated by Week 5, a computer-generated randomization sequence (Microsoft Excel) is applied weekly to assign them to either the intervention or control group. This weekly approach ensures the intervention is timely and integrated into the program's existing administrative workflow.
Intervention Logistics: The Intervention Group receives a one-way SMS reminder sent via the 'Alhora' platform, the secure institutional messaging system used by the screening program. The content of the SMS was previously optimized and validated through a qualitative pilot study involving semi-structured interviews to ensure high readability and cultural acceptability among the target population. Non-participants in both groups receive the standard postal reminder letter at Week 6.
Statistical Analysis Plan: The analysis will be conducted on both an intent-to-treat (ITT) and per-protocol basis. Descriptive statistics will report frequencies and medians with interquartile ranges (25th-75th percentiles). Bivariate analysis will utilize Chi-square tests for participation rates and the Mann-Whitney U test for response time differences. To estimate the effect size, Relative Risks (RR) with 95% confidence intervals will be calculated. Furthermore, a multivariate binary logistic regression will be performed using Jamovi software to adjust for potential confounders such as sex, age, geographic area, and history of previous participation
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 10,084 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
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
Participants receive the initial invitation letter at week 0. If they have not participated by week 5, an SMS text message reminder is sent. If they remain non-participants following the SMS, they receive the standard postal reminder letter at week 6.
Behavioral: Text Messaging · Behavioral: Standard invitation and postal reminder letters
Behavioral intervention consisting of a one-way short message service (SMS) text message sent to the mobile phones of participants who have not completed the fecal immunochemical test (FIT) following the initial invitation. A single SMS reminder is sent exactly 5 weeks after the issuance of the standard invitation letter, one week prior to the scheduled postal reminder. Delivery is centrally managed through the secure 'Alhora' messaging platform. The message format is validated through a qualitative pilot study to ensure readability and acceptability by the target population (aged 50-69 years).
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.
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 months after the initial invitation
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 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 months after the initial invitation.
Plan to share: No — 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.
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