- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04343950
SMS Messaging as a Tool to Improve Cancer Screening Programs (M-TICS)
Implementation of Text Messaging (SMS) as an Improvement Tool in Population-based Cancer Screening Programs
Study Overview
Status
Conditions
Detailed Description
Main Hypothesis:
The implementation of SMS in population-based cancer screening programs will improve participation, especially in colorectal cancer screening, will allow a better resource management and reduce costs in both programs.
Specific Hypothesis:
Sending the reminder SMS will have an impact on participation greater than that obtained with the standard reminder (letter) in the colorectal cancer screening program.
The effect of the colorectal cancer screening reminder SMS will be greater among the individuals who have been invited for the first time and not previous participants.
Participation after receiving the invitation by SMS in breast cancer screening will be equal to or better than the letter invitation.
The alternative that includes sending SMS will be cost-effective in relation to the current alternative that you use postal shipping.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
- Institut Catala d'Oncologia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eligible individuals for colorectal cancer screening (intervention 1 and 2)
- Eligible women for breast cancer screening (intervention 3)
- Registered at the HealthCare Database (RCA)
Exclusion Criteria:
- Individuals without a mobile phone number registered at the RCA
- Opt out from breast cancer screening and/or colorectal cancer screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention 1: SMS reminders in colorectal cancer screening
SMS reminders will be sent to individuals who received an invitation letter from Colorectal Cancer Screening Program and haven't participated within 6 weeks.
|
Individual randomization will be used.
Individuals assigned to the experimental arm with a wrong phone number will get a reminder letter (protocol analysis).
Other Names:
|
|
Active Comparator: Usual Care 1: Reminder letter in colorectal cancer screening
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.
|
Individual randomization will be used.
Individuals assigned to the experimental arm with a wrong phone number will get a reminder letter (protocol analysis).
Other Names:
|
|
Experimental: Intervention 2: SMS reminders to return the screening test
SMS reminders will be sent to individuals who picked the fecal immunochemical test at the pharmacy and haven't returned it within 14 days.
|
Individual randomization will be used.
Individuals with a wrong phone number assigned to the experimental arm will not get any reminder (protocol analysis).
Other Names:
|
|
Active Comparator: Usual Care 2: No intervention
No reminders will be sent.
|
Individual randomization will be used.
Individuals with a wrong phone number assigned to the experimental arm will not get any reminder (protocol analysis).
Other Names:
|
|
Experimental: Intervention 3: SMS invitation among prior participants
Invitation by SMS will be sent to women who previously participated in the Breast Cancer Screening Program.
|
Individual randomization.
Women assigned to the experimental arm and with a wrong phone number will get an invitation letter (protocol analysis).
Other Names:
|
|
Active Comparator: Usual Care 3: Invitation letter
Letter invitations will be sent.
|
Individual randomization.
Women assigned to the experimental arm and with a wrong phone number will get an invitation letter (protocol analysis).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention 1: Participation in colorectal cancer screening program
Time Frame: 18 weeks
|
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
Time Frame: 18 weeks
|
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
Time Frame: 8 weeks
|
Participation (no/yes) will be gathered prospectively 8 weeks after sending the screening invitation letter (week 0).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental cost ratio
Time Frame: 18 weeks
|
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.
|
18 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Montse Garcia, PhD, Institut Catala d'Oncologia
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Colorectal Neoplasms
- Breast Neoplasms
Other Study ID Numbers
- ICO_UCC_202001
- PI19/00226 (Other Grant/Funding Number: The National Institute of Health Carlos III (ISCIII))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage IIIB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast CancerUnited States
-
University of Central FloridaFlorida Department of HealthRecruitingBreast Cancer | Breast Cancer Female | Breast Cancer Diagnosis | Breast Cancer Survivors | Breast Cancer Detection | Breast Cancer AwarenessUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Invitation by SMS to previous participants in breast cancer screening:
-
Iaso Maternity Hospital, Athens, GreeceHarokopio UniversityCompletedObesity | Breast Cancer | Cardiovascular Disease OtherGreece
-
University of WarwickUniversity of Bristol; University of BirminghamEnrolling by invitationBreast CancerUnited Kingdom