Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer

Study Overview
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Brief Summary
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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
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The secondary objectives will be the following: To test the non-inferiority of interventions based on step 1a and step 1 (1a+1b), considering a non-inferiority limit of 5%; To test the superiority of the specific components of the multistage intervention corresponding to step 2 and step 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: Urban and rural areas; Younger and older population; Deprived and wealthy population; Never vs. ever users of screening; History of regular vs. irregular participation in screening programs. 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; 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.

Official Title
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Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews

Conditions
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Mass Screening, Early Detection of Cancer, Uterine Cervical Neoplasm, Text Message, Reminder Systems

Intervention / Treatment
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* Other: Customized text message invitation ( Step 1a)
* Other: Customized automatic phone call invitation (Step 1b)
* Other: Secretary phone call (Step 2)
* Other: Health professional face-to-face appointment (Step 3)
* Other: Written Letter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged between 25 and 49 years Medical registration at any of the primary health care units selected for this study Eligible for cervical cancer screening* *Defined as all women aged between 25 and 60 years old who do not verify any of the following criteria: hysterectomized, active cervical cancer disease, currently undergoing cervical cancer treatment or did not start sexual activity. Exclusion Criteria: Unavailability of mobile phone number

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepwise intervention<br>Stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening, implemented through three steps: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professional phone call and face-to-face appointment. Intervention stops whenever the participant adheres to organized screening or after undergoing the complete stepwise intervention. | Other: Customized text message invitation ( Step 1a)<br>* Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening<br>Other: Customized automatic phone call invitation (Step 1b)<br>* 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<br>Other: Secretary phone call (Step 2)<br>* 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)<br>Other: Health professional face-to-face appointment (Step 3)<br>* 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.<br>|
| Active Comparator: Written Letter<br>Comparator will be the standard of care of invitation to cervical cancer screening: written letter | Other: Written Letter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to cervical cancer screening (step1) | Proportion/cumulative proportion of women who performed cervical cancer screening on scheduled date, among those who were invited to undergo it, after step 1 or sequences of steps from 1 to 3 | Up to 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to cervical cancer screening (steps 1a, 2 and 3) | Proportion of women who performed cervical cancer screening on scheduled date, among those who were invited to undergo it, after step 1a, after step 2 or after step 3 | Up to 20 months | 
| Text message status | Proportion of received text messages, from those that were sent | Up to 20 months | 
| Automatic phone call status | Proportion of delivered automatic phone calls, from those that were sent | Up to 20 months | 
| Organized screening | Proportion of women undergoing cervical cancer screening in a private health institution who changed to organized cervical cancer screening | Up to 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Directive Counseling