Colorectal Neoplasms, Early Detection of Cancer
Conditions
Keywords
Colorectal Cancer Screening, Text Messaging, Fecal Occult Blood Test, Public Health, Patient Participation, Reminder Systems, SMS Reminders, mHealth, Cancer Prevention, Patient Adherence
Brief summary
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
Detailed description
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
Interventions
BEHAVIORALText Messaging
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).
BEHAVIORALStandard 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.
Sponsors
Corporacion Parc Tauli
Universitat Autonoma de Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Due to the nature of the behavioral intervention (sending an SMS reminder), masking of participants and investigators is not possible. However, to minimize bias, the primary outcome measure (participation) is objective, as it is automatically determined by the screening program's information system when the participant's sample is analyzed in the laboratory. Furthermore, statistical analysis will be performed on an anonymized database where the analyst will use unique identification codes dissociated from personal data.
Intervention model description
This is a pragmatic, randomized clinical trial with a parallel-group design and a 1:1 allocation ratio. Participants are randomly assigned to one of two study arms: the Intervention Group or the Control Group. Randomization is performed weekly using a computer-generated sequence (Microsoft Excel) applied to the target population that has not participated within 5 weeks of the initial invitation, ensuring an equitable distribution between both groups.
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation rate | 3 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to participation | 3 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 ). |
| Number of reminder letters sent | 3 months 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. |
Countries
Spain
Contacts
CONTACTAnna Selva Olid, PhD
CONTACTMarina Lleal Custey, PhD
PRINCIPAL_INVESTIGATORAnna Selva Olid, PhD, MPH, MD
Corporación Parc Taulí
Outcome results
None listed