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Impact of SMS Messaging on Participation in Colorectal Cancer Screening.

1. juni 2026 opdateret af: Anna Selva, Corporacion Parc Tauli

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10084

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Anna Selva Olid, PhD
  • Telefonnummer: 82240 +34937231010
  • E-mail: aselva@tauli.cat

Undersøgelse Kontakt Backup

  • Navn: Marina Lleal Custey, PhD
  • Telefonnummer: 82241 +34937231010
  • E-mail: mlleal@tauli.cat

Studiesteder

  • Spanien
    • Catalonia
      • Sabadell, Catalonia, Spanien, 08208
        • Rekruttering
        • Unitat de Cribratge de Cáncer, Consorci Corporació Sanitaria Parc Taulí
        • Kontakt:
          • Anna Selva Olid, PhD
          • Telefonnummer: 82240 +34937231010
          • E-mail: aselva@tauli.cat
        • Kontakt:
          • Marina Lleal Custey, PhD
          • Telefonnummer: 82239 +34937231010
          • E-mail: mlleal@tauli.cat
        • Ledende efterforsker:
          • Anna Selva Olid, PhD
        • Ledende efterforsker:
          • Marina Lleal Custey, PhD
        • Underforsker:
          • Cessia Vilcahuamán Esteban, RN, Sp

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Adfærdsmæssigt: Standard 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.
Eksperimentel: 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.
Adfærdsmæssigt: Standard 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.

Adfærdsmæssigt: Text Messaging
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participation rate
Tidsramme: 3 and 6 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.
3 and 6 months after the initial invitation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to participation
Tidsramme: 3 and 6 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 ).
3 and 6 months after the initial invitation (at the conclusion of the study follow-up).
Number of reminder letters sent
Tidsramme: 3 and 6months 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.
3 and 6months after the initial invitation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Corporacion Parc Tauli

Samarbejdspartnere

Universitat Autonoma de Barcelona

Efterforskere

  • Ledende efterforsker: Anna Selva Olid, PhD, MPH, MD, Corporación Parc Taulí

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. maj 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026.054-30

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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