Impact of SMS Messaging on Participation in Colorectal Cancer Screening.
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Anna Selva Olid, PhD
- Numer telefonu: 82240 +34937231010
- E-mail: aselva@tauli.cat
Kopia zapasowa kontaktu do badania
- Nazwa: Marina Lleal Custey, PhD
- Numer telefonu: 82241 +34937231010
- E-mail: mlleal@tauli.cat
Lokalizacje studiów
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Catalonia
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Sabadell, Catalonia, Hiszpania, 08208
- Rekrutacyjny
- Unitat de Cribratge de Cáncer, Consorci Corporació Sanitaria Parc Taulí
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Kontakt:
- Anna Selva Olid, PhD
- Numer telefonu: 82240 +34937231010
- E-mail: aselva@tauli.cat
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Kontakt:
- Marina Lleal Custey, PhD
- Numer telefonu: 82239 +34937231010
- E-mail: mlleal@tauli.cat
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Główny śledczy:
- Anna Selva Olid, PhD
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Główny śledczy:
- Marina Lleal Custey, PhD
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Pod-śledczy:
- Cessia Vilcahuamán Esteban, RN, Sp
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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.
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Control intervention based on the colorectal cancer screening program's usual standard of care. Components and Timing:
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. |
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Eksperymentalny: 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.
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Control intervention based on the colorectal cancer screening program's usual standard of care. Components and Timing:
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 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).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Participation rate
Ramy czasowe: 3 and 6 months after the initial invitation.
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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.
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3 and 6 months after the initial invitation.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Time to participation
Ramy czasowe: 3 and 6 months after the initial invitation (at the conclusion of the study follow-up).
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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 ).
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3 and 6 months after the initial invitation (at the conclusion of the study follow-up).
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Number of reminder letters sent
Ramy czasowe: 3 and 6months after the initial invitation.
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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.
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3 and 6months after the initial invitation.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Anna Selva Olid, PhD, MPH, MD, Corporación Parc Taulí
Publikacje i pomocne linki
Publikacje ogólne
- Shaukat A, Mongin SJ, Geisser MS, Lederle FA, Bond JH, Mandel JS, Church TR. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013 Sep 19;369(12):1106-14. doi: 10.1056/NEJMoa1300720.
- Vives N, Vidal C, de Guzman EN, Farre A, Panera JA, Binefa G, Garcia M; M-TICS research group. The use of text messages as an alternative invitation method for breast cancer screening: A randomized controlled trial (M-TICS study). PLoS One. 2024 Aug 29;19(8):e0306720. doi: 10.1371/journal.pone.0306720. eCollection 2024.
- Vives N, Travier N, Farre A, Binefa G, Vidal C, Perez Lacasta MJ, Ibanez-Sanz G, Nino de Guzman EP, Panera JA, Garcia M; M-TICS Research Group. Effectiveness and Acceptability of Targeted Text Message Reminders in Colorectal Cancer Screening: Randomized Controlled Trial (M-TICS Study). JMIR Public Health Surveill. 2024 Jul 31;10:e57959. doi: 10.2196/57959.
- Vives N, Farre A, Ibanez-Sanz G, Vidal C, Binefa G, Mila N, Perez-Lacasta MJ, Travier N, Benito L, Espinas JA, Bagaria G, Garcia M. Text messaging as a tool to improve cancer screening programs (M-TICS Study): A randomized controlled trial protocol. PLoS One. 2021 Jan 22;16(1):e0245806. doi: 10.1371/journal.pone.0245806. eCollection 2021.
- Hewitson P, Glasziou P, Irwig L, Towler B, Watson E. Screening for colorectal cancer using the faecal occult blood test, Hemoccult. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD001216. doi: 10.1002/14651858.CD001216.pub2.
- Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, Snover DC, Schuman LM. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med. 2000 Nov 30;343(22):1603-7. doi: 10.1056/NEJM200011303432203.
- Schliemann D, Tan MM, Hoe WMK, Mohan D, Taib NA, Donnelly M, Su TT. mHealth Interventions to Improve Cancer Screening and Early Detection: Scoping Review of Reviews. J Med Internet Res. 2022 Aug 15;24(8):e36316. doi: 10.2196/36316.
- Uy C, Lopez J, Trinh-Shevrin C, Kwon SC, Sherman SE, Liang PS. Text Messaging Interventions on Cancer Screening Rates: A Systematic Review. J Med Internet Res. 2017 Aug 24;19(8):e296. doi: 10.2196/jmir.7893.
- Camilloni L, Ferroni E, Cendales BJ, Pezzarossi A, Furnari G, Borgia P, Guasticchi G, Giorgi Rossi P; Methods to increase participation Working Group. Methods to increase participation in organised screening programs: a systematic review. BMC Public Health. 2013 May 13;13:464. doi: 10.1186/1471-2458-13-464.
Przydatne linki
- Programa de detecció precoç del càncer de còlon i recte del Vallès Occidental. Resultats ronda 4. Generalitat de Catalunya, Departament de Salut.
- European Comission. (March de 2024). Uncovering Inequalities. Obtenido de Colorrectal Cancer Screening in Europe.
- Plan Director de Oncología. (Junio de 2023). Estadísticas del cáncer en Cataluña durante el año 2022. Barcelona, España: Generalidad de Cataluña, Departamento de Salud.
- Lleal Custey, M., Selva Olid, A., Garró Gómez, A., & Ferrándiz Civil, A. (2025). Evaluación del impacto del envío de SMS en el programa de detección precoz de cáncer colorrectal. Gaceta Sanitaria, 39(S2), 205.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby jelit
- Nowotwory przewodu pokarmowego
- Nowotwory Układu Pokarmowego
- Choroby Układu Pokarmowego
- Choroby przewodu pokarmowego
- Nowotwory jelit
- Choroby odbytu
- Choroby okrężnicy
- Zachowanie
- Przestrzeganie i przestrzeganie zaleceń dotyczących leczenia
- Zachowanie zdrowotne
- Akceptacja opieki zdrowotnej przez pacjentów
- Nowotwory jelita grubego
- Udział pacjentów
- Zdyscyplinowanie pacjenta
Inne numery identyfikacyjne badania
- 2026.054-30
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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