<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03000920</url>
  </required_header>
  <id_info>
    <org_study_id>INCA15-KH/USIMaPI</org_study_id>
    <nct_id>NCT03000920</nct_id>
  </id_info>
  <brief_title>Evaluation of the Short Message Service Effectiveness in the Screening Invitation Strategy for Breast Cancer (USIMaPI)</brief_title>
  <acronym>USIMaPI</acronym>
  <official_title>Multicenter Randomized Controlled Trial Evaluating the Effectiveness and Cost-effectiveness of the Use of Short Message Service (SMS) in the Screening Invitation Strategy for Breast Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Each year in France, breast cancer affects about 48,000 women and is the first cause of&#xD;
      cancer death in women with 11,900 deaths estimated.&#xD;
&#xD;
      Since 2004, there is a national organized breast cancer screening (OBCS) programme for&#xD;
      asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer&#xD;
      screening department sends a personalized invitation mail to eligible women to perform a&#xD;
      mammogram and a breast clinical examination. One to two reminder mails are sent to women who&#xD;
      have not done the screening after an initial invitation. Despite this programme, almost 47%&#xD;
      of women in France do not participate to organized breast cancer screening.&#xD;
&#xD;
      The Short Message Service (SMS) is an innovative communication tool in the field of health,&#xD;
      immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative,&#xD;
      low-cost, personalized and ecological way to support the OBCS invitation strategy.&#xD;
&#xD;
      The overall objective of this study is to preserve or even better increase participation in&#xD;
      organized breast cancer screening while decreasing the associated costs by including SMS in&#xD;
      our screening invitation procedure.&#xD;
&#xD;
      Two SMS interventions will be tested which will correspond to different phases of the OBCS&#xD;
      invitation procedure. This sequence of interventions leads us to perform three interlinked&#xD;
      trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days&#xD;
      before the initial mail invitation), then two non-inferiority trials for the second phase (&#xD;
      two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the&#xD;
      first postal reminder).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year in France, breast cancer affects about 48,000 women and is the first cause of&#xD;
      cancer death in women with 11,900 deaths estimated.&#xD;
&#xD;
      Since 2004, there is a national organized breast cancer screening (OBCS) programme for&#xD;
      asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer&#xD;
      screening department sends a personalized invitation mail to eligible women to perform a&#xD;
      mammogram and a breast clinical examination. One to two reminder mails are sent to women who&#xD;
      have not done the screening after an initial invitation. Despite this programme, almost 47%&#xD;
      of women in France do not participate to organized breast cancer screening.&#xD;
&#xD;
      The Short Message Service (SMS) is an innovative communication tool in the field of health,&#xD;
      immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative,&#xD;
      low-cost, personalized and ecological way to support the OBCS invitation strategy.&#xD;
&#xD;
      In databases, there is currently about 10 to 15% of the women with a mobile phone number&#xD;
      registered in the target population.&#xD;
&#xD;
      This project will be carried out throughout the Region &quot;Centre-Val de Loire&quot; with six local&#xD;
      cancer screening departments The overall objective of this study is to preserve or even&#xD;
      better increase participation in organized breast cancer screening while decreasing the&#xD;
      associated costs by including SMS in our screening invitation procedure.&#xD;
&#xD;
      Two SMS interventions will be tested which will correspond to different phases of the OBCS&#xD;
      invitation procedure. This sequence of interventions leads us to perform three interlinked&#xD;
      trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days&#xD;
      before the initial mail invitation), then two non-inferiority trials for the second phase&#xD;
      (intervention 2: sending an SMS in place of the first postal reminder).&#xD;
&#xD;
      Justification of methodological choices&#xD;
&#xD;
        1. st phase: Addition of the intervention &quot;sending an SMS&quot; (and the associated cost) to&#xD;
           what is currently done (versus classical intervention). To be of interest, the tested&#xD;
           intervention, the sending of an SMS few days before the initial mail invitation, should&#xD;
           allow to significantly increase participation in OBCS (here superiority trial).&#xD;
&#xD;
        2. nd phase: This phase will involve women who have had or not the phase 1 intervention and&#xD;
           who have not yet participated to the OBCS. Since the contexts in phase 1 are different,&#xD;
           a trial for each one must be carry out. In this second phase, the conventional&#xD;
           intervention (sending reminder mail 1) will be compare to a cheaper one (sending&#xD;
           reminder 1 by SMS). The new strategy will prove interesting if it is not inferior in&#xD;
           terms of participation to the OBCS. The analysis of this non-inferiority will be carried&#xD;
           out for each context of phase 1 (invitation mail alone OR SMS then invitation mail).&#xD;
&#xD;
      The 4 groups of the study are the followings:&#xD;
&#xD;
        -  Group 1 (usual procedure): at least an invitation mail and then one or two reminder by&#xD;
           mail if necessary.&#xD;
&#xD;
        -  Group 2 : Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail&#xD;
           if necessary&#xD;
&#xD;
        -  Group 3 : One SMS a few days before the Invitation by mail and then one or two&#xD;
           reminder(s) by mail if necessary&#xD;
&#xD;
        -  Group 4 : One SMS a few days before the Invitation by mail then reminder 1 by SMS if&#xD;
           necessary then reminder 2 by mail if necessary&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: Compare the participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of sending an SMS before the invitation letter (vs sending the invitation letter alone = usual strategy).</measure>
    <time_frame>Before the sending time of the reminder 1 (letter or SMS) : from 3 months to 8 months after the invitation letter depending to periods of the concerned local cancer screening department</time_frame>
    <description>For this first phase, the study aims to demonstrate that the addition of the SMS is superior in terms of participation and participation costs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Compare participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of replacing the reminder 1 by mail with a reminder 1 by SMS ( reminder 1 mail = usual strategy).</measure>
    <time_frame>Before the sending time of the reminder 2 : from 3 months to 6 months after the reminder 1 depending to periods of the concerned local cancer screening department</time_frame>
    <description>For this second phase, the study aims to demonstrate the non-inferiority of the strategy including the SMS in terms of participation and cost-participation according to the two contexts:&#xD;
women who have already received an invitation letter alone.&#xD;
women who have already received one SMS and the invitation mail.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12000</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>1_Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Classic screening invitation strategy with at least an invitation mail and then one or two reminder by mail if necessary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2_SMS Reminder 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3_SMS before invitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One SMS a few days before the Invitation by mail and then one or two reminder(s) by mail if necessary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4_SMS before invitation + SMS Reminder 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One SMS a few days before the Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS before invitation</intervention_name>
    <description>A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram</description>
    <arm_group_label>3_SMS before invitation</arm_group_label>
    <arm_group_label>4_SMS before invitation + SMS Reminder 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS Reminder 1</intervention_name>
    <description>If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.</description>
    <arm_group_label>2_SMS Reminder 1</arm_group_label>
    <arm_group_label>4_SMS before invitation + SMS Reminder 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  eligible to the organized breast cancer screening&#xD;
&#xD;
          -  residing in the region of Centre-Val de Loire (France)&#xD;
&#xD;
          -  Phone number registered in data bases of one of the 6 local cancer screening&#xD;
             departments of the region of Centre-Val de Loire (France)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ken HAGUENOER, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de Coordination des Dépistages des Cancers, CHRU de Tours</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Somany SENGCHANH, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de Coordination des Dépistages des Cancers, CHRU de Tours</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julie Boyard</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de Coordination des Dépistages des Cancers, CHRU de Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ADOC41</name>
      <address>
        <city>Blois</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ADOC28</name>
      <address>
        <city>Chartres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CREDEP</name>
      <address>
        <city>Châteauroux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCDC</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>short message service (SMS)</keyword>
  <keyword>screening</keyword>
  <keyword>cost-effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000920
org study id: INCA15-KH/USIMaPI
nct id: NCT03000920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Each year in France, breast cancer affects about 48,000 women and is the first cause of
      cancer death in women with 11,900 deaths estimated.

      Since 2004, there is a national organized breast cancer screening (OBCS) programme for
      asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer
      screening department sends a personalized invitation mail to eligible women to perform a
      mammogram and a breast clinical examination. One to two reminder mails are sent to women who
      have not done the screening after an initial invitation. Despite this programme, almost 47%
      of women in France do not participate to organized breast cancer screening.

      The Short Message Service (SMS) is an innovative communication tool in the field of health,
      immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative,
      low-cost, personalized and ecological way to support the OBCS invitation strategy.

      The overall objective of this study is to preserve or even better increase participation in
      organized breast cancer screening while decreasing the associated costs by including SMS in
      our screening invitation procedure.

      Two SMS interventions will be tested which will correspond to different phases of the OBCS
      invitation procedure. This sequence of interventions leads us to perform three interlinked
      trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days
      before the initial mail invitation), then two non-inferiority trials for the second phase (
      two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the
      first postal reminder).
Each year in France, breast cancer affects about 48,000 women and is the first cause of
      cancer death in women with 11,900 deaths estimated.

      Since 2004, there is a national organized breast cancer screening (OBCS) programme for
      asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer
      screening department sends a personalized invitation mail to eligible women to perform a
      mammogram and a breast clinical examination. One to two reminder mails are sent to women who
      have not done the screening after an initial invitation. Despite this programme, almost 47%
      of women in France do not participate to organized breast cancer screening.

      The Short Message Service (SMS) is an innovative communication tool in the field of health,
      immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative,
      low-cost, personalized and ecological way to support the OBCS invitation strategy.

      In databases, there is currently about 10 to 15% of the women with a mobile phone number
      registered in the target population.

      This project will be carried out throughout the Region "Centre-Val de Loire" with six local
      cancer screening departments The overall objective of this study is to preserve or even
      better increase participation in organized breast cancer screening while decreasing the
      associated costs by including SMS in our screening invitation procedure.

      Two SMS interventions will be tested which will correspond to different phases of the OBCS
      invitation procedure. This sequence of interventions leads us to perform three interlinked
      trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days
      before the initial mail invitation), then two non-inferiority trials for the second phase
      (intervention 2: sending an SMS in place of the first postal reminder).

      Justification of methodological choices

        1. st phase: Addition of the intervention "sending an SMS" (and the associated cost) to
           what is currently done (versus classical intervention). To be of interest, the tested
           intervention, the sending of an SMS few days before the initial mail invitation, should
           allow to significantly increase participation in OBCS (here superiority trial).

        2. nd phase: This phase will involve women who have had or not the phase 1 intervention and
           who have not yet participated to the OBCS. Since the contexts in phase 1 are different,
           a trial for each one must be carry out. In this second phase, the conventional
           intervention (sending reminder mail 1) will be compare to a cheaper one (sending
           reminder 1 by SMS). The new strategy will prove interesting if it is not inferior in
           terms of participation to the OBCS. The analysis of this non-inferiority will be carried
           out for each context of phase 1 (invitation mail alone OR SMS then invitation mail).

      The 4 groups of the study are the followings:

        -  Group 1 (usual procedure): at least an invitation mail and then one or two reminder by
           mail if necessary.

        -  Group 2 : Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail
           if necessary

        -  Group 3 : One SMS a few days before the Invitation by mail and then one or two
           reminder(s) by mail if necessary

        -  Group 4 : One SMS a few days before the Invitation by mail then reminder 1 by SMS if
           necessary then reminder 2 by mail if necessary
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Phase 1: Compare the participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of sending an SMS before the invitation letter (vs sending the invitation letter alone = usual strategy).
time frame: Before the sending time of the reminder 1 (letter or SMS) : from 3 months to 8 months after the invitation letter depending to periods of the concerned local cancer screening department
description: For this first phase, the study aims to demonstrate that the addition of the SMS is superior in terms of participation and participation costs.
measure: Phase 2: Compare participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of replacing the reminder 1 by mail with a reminder 1 by SMS ( reminder 1 mail = usual strategy).
time frame: Before the sending time of the reminder 2 : from 3 months to 6 months after the reminder 1 depending to periods of the concerned local cancer screening department
description: For this second phase, the study aims to demonstrate the non-inferiority of the strategy including the SMS in terms of participation and cost-participation according to the two contexts:
women who have already received an invitation letter alone.
women who have already received one SMS and the invitation mail.
arm group label: 1_Control
arm group type: No Intervention
description: Classic screening invitation strategy with at least an invitation mail and then one or two reminder by mail if necessary.
arm group label: 2_SMS Reminder 1
arm group type: Experimental
description: Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary
arm group label: 3_SMS before invitation
arm group type: Experimental
description: One SMS a few days before the Invitation by mail and then one or two reminder(s) by mail if necessary.
arm group label: 4_SMS before invitation + SMS Reminder 1
arm group type: Experimental
description: One SMS a few days before the Invitation by mail then reminder 1 by SMS if necessary then reminder 2 by mail if necessary
intervention type: Other
intervention name: SMS before invitation
description: A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram
arm group label: 3_SMS before invitation
arm group label: 4_SMS before invitation + SMS Reminder 1
intervention type: Other
intervention name: SMS Reminder 1
description: If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
arm group label: 2_SMS Reminder 1
arm group label: 4_SMS before invitation + SMS Reminder 1
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: No
last name: ken HAGUENOER, Dr
role: Principal Investigator
affiliation: Centre de Coordination des Dépistages des Cancers, CHRU de Tours
last name: Somany SENGCHANH, Dr
role: Principal Investigator
affiliation: Centre de Coordination des Dépistages des Cancers, CHRU de Tours
last name: Julie Boyard
role: Principal Investigator
affiliation: Centre de Coordination des Dépistages des Cancers, CHRU de Tours
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No