About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Personal history of colorectal cancer.
Inflammatory bowel disease (IBD)
Colorectal polyps requiring specific clinical follow-up.
Hereditary polyposis syndromes.
Trial design
Parallel
Treatments tested in this trial
Text Messaging
BehavioralBehavioral 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).
Standard invitation and postal reminder letters
BehavioralControl 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.
Treatment groups
Trial 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
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 ).
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.
Sponsors and contacts
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Corporacion Parc Tauli
Lead sponsor
Universitat Autonoma de Barcelona
Collaborator