Impact of SMS Messaging on Participation in Colorectal Cancer Screening.

NCT07628998 | Recruiting

• 1 other identifier: 2026.054-30
• Study Type: interventional
• Target: 10,084
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms; Early Detection of Cancer

Keywords

Colorectal Cancer Screening; Text Messaging; Fecal Occult Blood Test; Public Health; Patient Participation; Reminder Systems; SMS Reminders; mHealth; Cancer Prevention; Patient Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  3 and 6 months after the initial invitation.

Secondary Outcomes (2)

• Time to participation

  3 and 6 months after the initial invitation (at the conclusion of the study follow-up).

• Number of reminder letters sent

  3 and 6months after the initial invitation.

Study Arms (2)

Control Group: Standard Care

ACTIVE COMPARATOR

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

Intervention Group: SMS + Standard Care

EXPERIMENTAL

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.

Behavioral: Text Messaging; Behavioral: Standard invitation and postal reminder letters

Interventions

Text Messaging BEHAVIORAL

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).

Intervention Group: SMS + Standard Care

Standard invitation and postal reminder letters BEHAVIORAL

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.

Control Group: Standard Care; Intervention Group: SMS + Standard Care

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Unitat de Cribratge de Cáncer, Consorci Corporació Sanitaria Parc Taulí

Sabadell, Catalonia, 08208, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 17253456 BACKGROUND

• 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.

  PMID: 11096167 BACKGROUND

• 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.

  PMID: 24047060 BACKGROUND

• 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.

  PMID: 35969450 BACKGROUND

• 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.

  PMID: 28838885 BACKGROUND

• 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.

  PMID: 23663511 BACKGROUND

• 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.

  PMID: 39208325 BACKGROUND

• 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.

  PMID: 39083331 BACKGROUND

• 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.

  PMID: 33481914 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Participation; Patient Compliance

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anna Selva Olid, PhD, MPH, MD

  Corporación Parc Taulí

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Selva Olid, PhD

CONTACT

+34937231010; aselva@tauli.cat

Marina Lleal Custey, PhD

CONTACT

+34937231010; mlleal@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)