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Colorectal NeoplasmsNCT07628998

Impact of SMS Messaging on Participation in Colorectal Cancer Screening

A study testing Text Messaging and Standard invitation and postal reminder letters in people with Colorectal Neoplasms and Early Detection of Cancer, run by Corporacion Parc Tauli at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 69 yearsHealthy volunteers can take part
What is being tested?
Text Messaging and Standard invitation and postal reminder letters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,084 participants
Where
1 siteSpain
Study dates
5 May 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Selva Olid, PhD contact

+34937231010 ext. 82240

aselva@tauli.cat

Marina Lleal Custey, PhD contact

+34937231010 ext. 82241

mlleal@tauli.cat

Spain1 site, 1 recruiting

  • Unitat de Cribratge de Cáncer, Consorci Corporació Sanitaria Parc Taulí

    Sabadell, Catalonia, 08208

    Anna Selva Olid, PhD, +34937231010 ext. 82240, aselva@tauli.cat

    Marina Lleal Custey, PhD, +34937231010 ext. 82239, mlleal@tauli.cat

    Recruiting

Other trials in Spain

About this study

Official title: 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

Read the 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

Being tested
Text Messaging, Standard invitation and postal reminder letters
Keywords
Colorectal Cancer Screening, Text Messaging, Fecal Occult Blood Test, Public Health, Patient Participation, Reminder Systems, SMS Reminders, mHealth, Cancer Prevention, Patient Adherence
Medical subject headings
Colorectal Neoplasms, Patient Participation, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text MessagingBehavioural

    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).

  • Standard invitation and postal reminder lettersBehavioural

    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.

Study groups in NCT07628998
Study groupRoleWhat they receive
Control Group: Standard CareActive comparatorParticipants 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.
Receives: Behavioral: Standard invitation and postal reminder letters
Intervention Group: SMS + Standard CareExperimentalParticipants 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.
Receives: Behavioral: Text Messaging; Behavioral: Standard invitation and postal reminder letters

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months after the initial invitation

Secondary outcomes (2)

  1. Time to participation

    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 ).

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

  2. Number of reminder letters sent

    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.

    Measured: 3 months after the initial invitation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start5 May 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
10,084 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628998
Sponsor's protocol ID
2026.054-30
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 17253456

  • 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.

    PubMed 11096167

  • 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.

    PubMed 24047060

  • 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.

    PubMed 35969450

  • 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.

    PubMed 28838885

  • 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.

    PubMed 23663511

  • 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.

    PubMed 39208325

  • 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.

    PubMed 39083331

  • 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.

    PubMed 33481914

Questions about this trial

What is this clinical trial studying?

A study testing Text Messaging and Standard invitation and postal reminder letters in people with Colorectal Neoplasms and Early Detection of Cancer, run by Corporacion Parc Tauli at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Selva Olid, PhD (+34937231010 ext. 82240, aselva@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation rate (time frame: 3 months after the initial invitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628998, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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