Evaluation of the Short Message Service Effectiveness in the Screening Invitation Strategy for Breast Cancer (USIMaPI)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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
    

Intervention name(s): SMS before invitation; SMS Reminder 1
Intervention type(s): Other; Other
Intervention description(s): A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram; If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: short message service (SMS); screening; cost-effectiveness