Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Facies

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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.

Comparator will be the standard of care of invitation to cervical cancer screening: written letter

Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening

Customized text message invitation ( Step 1a)

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

Customized automatic phone call invitation (Step 1b)

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)

Secretary phone call (Step 2)

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.

Health professional face-to-face appointment (Step 3)

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.

Written Letter

Firmino DB Machado, MD

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.

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.

Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer

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

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

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

Proportion of received text messages, from those that were sent

Proportion of delivered automatic phone calls, from those that were sent

Proportion of women undergoing cervical cancer screening in a private health institution who changed to organized cervical cancer screening

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer	NCT03122275	Mass Screening Early Detection... Uterine Cervica... Text Message Reminder System...	Customized text... Customized auto... Secretary phone... Health professi... Written Letter	25 Years - 49 Years	Universidade do Porto
Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer	NCT03122275	Mass Screening Early Detection... Uterine Cervica... Text Message Reminder System...	Customized text... Customized auto... Secretary phone... Health professi... Written Letter	25 Years - 49 Years	Universidade do Porto

Spots Global Cancer Trial Database for customized automatic phone call invitation (step 1b)