Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer (SCAN-CC)
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|ClinicalTrials.gov Identifier: NCT03122275|
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : May 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Mass Screening Early Detection of Cancer Uterine Cervical Neoplasm Text Message Reminder Systems||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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews|
|Actual Study Start Date :||April 27, 2017|
|Actual Primary Completion Date :||April 27, 2018|
|Actual Study Completion Date :||April 27, 2018|
Experimental: Stepwise intervention
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)
Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening
Other: Customized automatic phone call invitation (Step 1b)
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
Other: Secretary phone call (Step 2)
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)
Other: Health professional face-to-face appointment (Step 3)
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.
Active Comparator: Written Letter
Comparator will be the standard of care of invitation to cervical cancer screening: written letter
Other: Written Letter
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.
- Adherence to cervical cancer screening (step1) [ Time Frame: Up to 20 months ]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
- Adherence to cervical cancer screening (steps 1a, 2 and 3) [ Time Frame: Up to 20 months ]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
- Text message status [ Time Frame: Up to 20 months ]Proportion of received text messages, from those that were sent
- Automatic phone call status [ Time Frame: Up to 20 months ]Proportion of delivered automatic phone calls, from those that were sent
- Organized screening [ Time Frame: Up to 20 months ]Proportion of women undergoing cervical cancer screening in a private health institution who changed to organized cervical cancer screening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122275
|ACeS Porto Ocidental|
|Porto, Portugal, 4100|
|ACeS Marão e Douro Norte|
|Vila Real, Portugal, 5000|
|Principal Investigator:||Firmino DB Machado, MD||EPIUnit - Instituto de Saúde Pública da Universidade do Porto|