Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer (SCAN-CC)

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

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.

Study Overview

• Status: Completed
• Conditions: Reminder Systems; Uterine Cervical Neoplasm; Mass Screening; Early Detection of Cancer; Text Message
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 1220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4100
    • ACeS Porto Ocidental
  • Vila Real, Portugal, 5000
    • ACeS Marão e Douro Norte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: João Firmino Domingues Barbosa Machado
• Collaborators: Universidade do Porto
• Investigators: Principal Investigator: Firmino DB Machado, MD, EPIUnit - Instituto de Saúde Pública da Universidade do Porto

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
• Firmino-Machado J, Varela S, Mendes R, Moreira A, Lunet N; SCAN-Cervical Cancer collaborators. A 3-step intervention to improve adherence to cervical cancer screening: The SCAN randomized controlled trial. Prev Med. 2019 Jun;123:250-261. doi: 10.1016/j.ypmed.2019.03.025. Epub 2019 Mar 30.
• Firmino-Machado J, Varela S, Mendes R, Moreira A, Lunet N; SCAN-Cervical Cancer collaborators. Stepwise strategy to improve cervical cancer screening adherence (SCAN-Cervical Cancer) - Automated text messages, phone calls and reminders: Population based randomized controlled trial. Prev Med. 2018 Sep;114:123-133. doi: 10.1016/j.ypmed.2018.06.004. Epub 2018 Jun 9.
• Firmino-Machado J, Mendes R, Moreira A, Lunet N. Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial. BMJ Open. 2017 Oct 5;7(10):e017730. doi: 10.1136/bmjopen-2017-017730.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2017
• Primary Completion (Actual): April 27, 2018
• Study Completion (Actual): April 27, 2018

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Adherence; Directive Counseling
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: EPIUnit_SCANCC_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No