NCT04343950

Brief Summary

The aim of this project is to assess the impact on health and economics of the implementation of text messaging (SMS) in cancer screening programs. Three interventions with SMS will be evaluated through community trials. In the colorectal cancer screening program the following interventions will be tested: a) Participation reminder: six weeks after sending the invitation letter of the colorectal cancer program if there has not been a response, a reminder SMS will be sent in front of the usual method by letter; b) Reminder to return the fecal occult blood test: SMS reminder of test delivery versus no intervention. This reminder will be sent to the individuals who have gone to the pharmacy to pick up a fecal occult blood test and they have not returned it after 14 days. The impact on participation will be analyzed and, if applicable, the proportion of advanced neoplasms will be calculated by increase in participation. In the breast cancer screening program, the invitation by SMS versus the usual invitation by letter will be studied in women who had participated in the previous screening round. The impact on participation will be analyzed. A cost-effectiveness analysis of the three interventions will be carried out. The incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44,601

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 5, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

April 9, 2020

Last Update Submit

September 18, 2025

Conditions

Keywords

UptakeParticipationCost-effectivenessBreast cancer screeningColorectal cancer screeningText-messageMobile-health

Outcome Measures

Primary Outcomes (3)

  • Intervention 1: Participation in colorectal cancer screening program

    Participation (no/yes) will be gathered prospectively 18 weeks after sending the screening invitation letter (week 0).

    18 weeks

  • Intervention 2: Participation in colorectal cancer screening program among individuals who pick the test at the pharmacy

    Participation (no/yes) among those individuals who pick the screening test for colorectal cancer at the pharmacy 18 weeks after sending the screening invitation letter (week 0).

    18 weeks

  • Intervention 3: Participation in breast cancer screening program

    Participation (no/yes) will be gathered prospectively 8 weeks after sending the screening invitation letter (week 0).

    8 weeks

Secondary Outcomes (1)

  • Incremental cost ratio

    18 weeks

Study Arms (6)

Intervention 1: SMS reminders in colorectal cancer screening

EXPERIMENTAL

SMS reminders will be sent to individuals who received an invitation letter from Colorectal Cancer Screening Program and haven't participated within 6 weeks.

Behavioral: SMS reminders to enhance colorectal cancer screening

Usual Care 1: Reminder letter in colorectal cancer screening

ACTIVE COMPARATOR

Reminder letters will be sent to individuals who received an invitation letter from the Colorectal Cancer Screening Program and haven't participated within 6 weeks.

Behavioral: SMS reminders to enhance colorectal cancer screening

Intervention 2: SMS reminders to return the screening test

EXPERIMENTAL

SMS reminders will be sent to individuals who picked the fecal immunochemical test at the pharmacy and haven't returned it within 14 days.

Behavioral: SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:

Usual Care 2: No intervention

ACTIVE COMPARATOR

No reminders will be sent.

Behavioral: SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:

Intervention 3: SMS invitation among prior participants

EXPERIMENTAL

Invitation by SMS will be sent to women who previously participated in the Breast Cancer Screening Program.

Behavioral: Invitation by SMS to previous participants in breast cancer screening:

Usual Care 3: Invitation letter

ACTIVE COMPARATOR

Letter invitations will be sent.

Behavioral: Invitation by SMS to previous participants in breast cancer screening:

Interventions

Individual randomization will be used. Individuals assigned to the experimental arm with a wrong phone number will get a reminder letter (protocol analysis).

Also known as: Intervention 1
Intervention 1: SMS reminders in colorectal cancer screeningUsual Care 1: Reminder letter in colorectal cancer screening

Individual randomization will be used. Individuals with a wrong phone number assigned to the experimental arm will not get any reminder (protocol analysis).

Also known as: Intervention 2
Intervention 2: SMS reminders to return the screening testUsual Care 2: No intervention

Individual randomization. Women assigned to the experimental arm and with a wrong phone number will get an invitation letter (protocol analysis).

Also known as: Intervention 3
Intervention 3: SMS invitation among prior participantsUsual Care 3: Invitation letter

Eligibility Criteria

Age50 Years - 69 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIntervention 1 and 2: both sexes. Intervention 3: only women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible individuals for colorectal cancer screening (intervention 1 and 2)
  • Eligible women for breast cancer screening (intervention 3)
  • Registered at the HealthCare Database (RCA)

You may not qualify if:

  • Individuals without a mobile phone number registered at the RCA
  • Opt out from breast cancer screening and/or colorectal cancer screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (4)

  • Vives N, Binefa G, Travier N, Farre A, Panera JA, Casas B, Vidal C, Ibanez-Sanz G, Garcia M; M-TICS research group. Text Messaging Versus Postal Reminders to Improve Participation in a Colorectal Cancer Screening Program: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 1;13:e64243. doi: 10.2196/64243.

    PMID: 39742454BACKGROUND
  • 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: 39208325BACKGROUND
  • 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: 39083331BACKGROUND
  • 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: 33481914BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Montse Garcia, PhD

    Institut Català d'Oncologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Invited individuals to the cancer screening programs will not be aware of the different arms of the study.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Intervention 1: SMS reminders for colorectal cancer screening compared to reminder letters. Intervention 2: SMS reminders to return the fecal occult blood test at the pharmacy compared to no intervention. Intervention 3: Invitation by SMS for women with a prior participation in the breast cancer screening program compared to invitation letter.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

June 5, 2021

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations