Impact of SMS Messaging on Participation in Colorectal Cancer Screening
Impact of SMS Notifications on the Colorectal Cancer Screening Program
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Anna Selva Olid, PhD
- Número de telefone: 82240 +34937231010
- E-mail: aselva@tauli.cat
Estude backup de contato
- Nome: Marina Lleal Custey, PhD
- Número de telefone: 82241 +34937231010
- E-mail: mlleal@tauli.cat
Locais de estudo
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Catalonia
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Sabadell, Catalonia, Espanha, 08208
- Recrutamento
- Unitat de Cribratge de Cáncer, Consorci Corporació Sanitaria Parc Taulí
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Contato:
- Anna Selva Olid, PhD
- Número de telefone: 82240 +34937231010
- E-mail: aselva@tauli.cat
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Contato:
- Marina Lleal Custey, PhD
- Número de telefone: 82239 +34937231010
- E-mail: mlleal@tauli.cat
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Investigador principal:
- Anna Selva Olid, PhD
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Investigador principal:
- Marina Lleal Custey, PhD
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Subinvestigador:
- Cessia Vilcahuamán Esteban, RN, Sp
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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Experimental: Intervention Group: SMS + Standard Care
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.
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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 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).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participation rate
Prazo: 3 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 months after the initial invitation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to participation
Prazo: 3 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 months after the initial invitation (at the conclusion of the study follow-up).
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Number of reminder letters sent
Prazo: 3 months 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 months after the initial invitation.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anna Selva Olid, PhD, MPH, MD, Corporacion Parc Tauli
Publicações e links úteis
Publicações Gerais
- 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.
Links úteis
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças Intestinais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças do cólon
- Comportamento
- Adesão e Cumprimento do Tratamento
- Comportamento de saúde
- Aceitação dos Cuidados de Saúde pelo Paciente
- Neoplasias Colorretais
- Participação do paciente
- Conformidade do paciente
Outros números de identificação do estudo
- 2026.054-30
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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