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SMS Messaging as a Tool to Improve Cancer Screening Programs (M-TICS)

Primary Purpose

Mass Screening, Colorectal Cancer, Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS reminders to enhance colorectal cancer screening
SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:
Invitation by SMS to previous participants in breast cancer screening:
Sponsored by
Institut Català d'Oncologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mass Screening focused on measuring Uptake, Participation, Cost-effectiveness, Breast cancer screening, Colorectal cancer screening, Text-message, Mobile-health

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Intervention 1: SMS reminders in colorectal cancer screening

    Usual Care 1: Reminder letter in colorectal cancer screening

    Intervention 2: SMS reminders to return the screening test

    Usual Care 2: No intervention

    Intervention 3: SMS invitation among prior participants

    Usual Care 3: Invitation letter

    Arm Description

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

    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.

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

    No reminders will be sent.

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

    Letter invitations will be sent.

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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).

    Secondary Outcome Measures

    Incremental cost ratio
    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.

    Full Information

    First Posted
    April 9, 2020
    Last Updated
    April 14, 2020
    Sponsor
    Institut Català d'Oncologia
    Collaborators
    University of Dundee, University of Barcelona, University Rovira i Virgili
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04343950
    Brief Title
    SMS Messaging as a Tool to Improve Cancer Screening Programs
    Acronym
    M-TICS
    Official Title
    Implementation of Text Messaging (SMS) as an Improvement Tool in Population-based Cancer Screening Programs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Català d'Oncologia
    Collaborators
    University of Dundee, University of Barcelona, University Rovira i Virgili

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mass Screening, Colorectal Cancer, Breast Cancer
    Keywords
    Uptake, Participation, Cost-effectiveness, Breast cancer screening, Colorectal cancer screening, Text-message, Mobile-health

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Masking Description
    Invited individuals to the cancer screening programs will not be aware of the different arms of the study.
    Allocation
    Randomized
    Enrollment
    20000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention 1: SMS reminders in colorectal cancer screening
    Arm Type
    Experimental
    Arm Description
    SMS reminders will be sent to individuals who received an invitation letter from Colorectal Cancer Screening Program and haven't participated within 6 weeks.
    Arm Title
    Usual Care 1: Reminder letter in colorectal cancer screening
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Intervention 2: SMS reminders to return the screening test
    Arm Type
    Experimental
    Arm Description
    SMS reminders will be sent to individuals who picked the fecal immunochemical test at the pharmacy and haven't returned it within 14 days.
    Arm Title
    Usual Care 2: No intervention
    Arm Type
    Active Comparator
    Arm Description
    No reminders will be sent.
    Arm Title
    Intervention 3: SMS invitation among prior participants
    Arm Type
    Experimental
    Arm Description
    Invitation by SMS will be sent to women who previously participated in the Breast Cancer Screening Program.
    Arm Title
    Usual Care 3: Invitation letter
    Arm Type
    Active Comparator
    Arm Description
    Letter invitations will be sent.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SMS reminders to enhance colorectal cancer screening
    Other Intervention Name(s)
    Intervention 1
    Intervention Description
    Cluster randomization instead of individual randomization will be used. The cluster will be "invitation week". Individuals assigned to the experimental arm with a wrong phone number will get a reminder letter (protocol analysis).
    Intervention Type
    Behavioral
    Intervention Name(s)
    SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:
    Other Intervention Name(s)
    Intervention 2
    Intervention Description
    Cluster randomization instead of individual randomization will be used. The cluster will be "invitation week". Individuals with a wrong phone number assigned to the experimental arm will not get any reminder (protocol analysis).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Invitation by SMS to previous participants in breast cancer screening:
    Other Intervention Name(s)
    Intervention 3
    Intervention Description
    Individual randomization. Women assigned to the experimental arm and with a wrong phone number will get an invitation letter (protocol analysis).
    Primary Outcome Measure Information:
    Title
    Intervention 1: Participation in colorectal cancer screening program
    Description
    Participation (no/yes) will be gathered prospectively 18 weeks after sending the screening invitation letter (week 0).
    Time Frame
    18 weeks
    Title
    Intervention 2: Participation in colorectal cancer screening program among individuals who pick the test at the pharmacy
    Description
    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).
    Time Frame
    18 weeks
    Title
    Intervention 3: Participation in breast cancer screening program
    Description
    Participation (no/yes) will be gathered prospectively 8 weeks after sending the screening invitation letter (week 0).
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Incremental cost ratio
    Description
    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.
    Time Frame
    18 weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Intervention 1 and 2: both sexes. Intervention 3: only women.
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Montse Garcia, PhD
    Phone
    +34932607205
    Email
    mgarcia@iconcologia.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nuria Vives, MD
    Phone
    +34932607205
    Email
    nvives@iconcologia.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Montse Garcia, PhD
    Organizational Affiliation
    Institut Català d'Oncologia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33481914
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    SMS Messaging as a Tool to Improve Cancer Screening Programs

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