Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer
Condition: Mass Screening; Early Detection of Cancer; Uterine Cervical Neoplasm; Text Message; Reminder Systems
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This study aims to assess the effectiveness of a stepwise approach, with increasing
      complexity and cost, to improve adherence to organized cervical cancer screening: step 1a -
      customized text message invitation; step 1b - customized automatic phone call invitation;
      step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.

      A population-based randomized controlled trial will be implemented in Portuguese urban and
      rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to
      intervention and control. In the intervention group, women will be invited for screening
      through text messages, automatic phone calls, manual phone calls and health professional
      appointments, to be applied sequentially to participants remaining non-adherent after each
      step. Control will be the standard of care (invitation by written letter).

      As primary objectives, we intend to test the superiority of interventions based on step 1
      (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on
      intention-to-treat analyses.
    

Detailed description: 
      The secondary objectives will be the following:

        1. To test the non-inferiority of interventions based on step 1a and step 1 (1a+1b),
           considering a non-inferiority limit of 5%;

        2. To test the superiority of the specific components of the multistage intervention
           corresponding to step 2 and step 3;

        3. To quantify the differences in adherence to cervical cancer screening, for interventions
           based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1
           to 3, between:

             1. Urban and rural areas;

             2. Younger and older population;

             3. Deprived and wealthy population;

             4. Never vs. ever users of screening;

             5. History of regular vs. irregular participation in screening programs.

        4. To quantify the differences in adherence to cervical cancer screening when using a
           positive or a neutral content of text messages and automatic phone calls, in step 1;

        5. To estimate the proportion of women who were performing cervical cancer screening in
           private health care services who started to be screened in an organized cervical cancer
           screening program, after a nurse face-to-face appointment at their primary care unit.

      Intention-to-treat analysis will be used as primary strategy for all comparisons between
      interventions and control. Secondary per-protocol analysis will also be conducted. Binary
      logistic regression may be used to control for confounding, or in secondary analyses of the
      isolate effects of steps 1a, 2 and 3.
    

Intervention name(s): Customized text message invitation ( Step 1a); Customized automatic phone call invitation (Step 1b); Secretary phone call (Step 2); Health professional face-to-face appointment (Step 3); Written Letter
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening; Personalized phone call, not operator dependent, automatically sent by Smart-Interactive Voice Response v.1.1 software These phone calls intend to invite women to cervical cancer screening; Manual phone call, performed by a trained secretary. These phone calls invite women to cervical cancer screening, but will only be used after automatic strategies (customized text messages and phone calls); Women randomized to experimental arm, who do not undergo cervical cancer screening after automatic invitation or manual phone call, receive this intervention. First, women are contacted through a phone call, performed by a health professional, inviting them for a face-to-face appointment at her primary care unit.
During appointments, the health professional understands possible barriers felt by women for not undergoing cervical cancer screening. Health professionals will try to overcome these barriers, using pre-defined arguments and facts. Finally, women are invited to perform screening.; A written letter will be used to invite eligible women to cervical cancer screening.
This intervention will be used only for women randomized to active comparator arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Adherence; Directive Counseling