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

Primary Purpose

Mass Screening, Early Detection of Cancer, Uterine Cervical Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
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
Sponsored by
João Firmino Domingues Barbosa Machado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Mass Screening focused on measuring Adherence, Directive Counseling

Eligibility Criteria

25 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • ACeS Porto Ocidental
  • ACeS Marão e Douro Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepwise intervention

Written Letter

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Text message status
Proportion of received text messages, from those that were sent
Automatic phone call status
Proportion of delivered automatic phone calls, from those that were sent
Organized screening
Proportion of women undergoing cervical cancer screening in a private health institution who changed to organized cervical cancer screening

Full Information

First Posted
April 11, 2017
Last Updated
May 1, 2018
Sponsor
João Firmino Domingues Barbosa Machado
Collaborators
Universidade do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT03122275
Brief Title
Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer
Acronym
SCAN-CC
Official Title
Stepwise Strategy to Improve Cervical Cancer Screening Adherence (SCAN-CC): Automatic Text Messages, Phone Calls and Face-to-face Interviews
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
João Firmino Domingues Barbosa Machado
Collaborators
Universidade do Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mass Screening, Early Detection of Cancer, Uterine Cervical Neoplasm, Text Message, Reminder Systems
Keywords
Adherence, Directive Counseling

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepwise intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Written Letter
Arm Type
Active Comparator
Arm Description
Comparator will be the standard of care of invitation to cervical cancer screening: written letter
Intervention Type
Other
Intervention Name(s)
Customized text message invitation ( Step 1a)
Intervention Description
Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening
Intervention Type
Other
Intervention Name(s)
Customized automatic phone call invitation (Step 1b)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Secretary phone call (Step 2)
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Health professional face-to-face appointment (Step 3)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Written Letter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to cervical cancer screening (step1)
Description
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
Time Frame
Up to 20 months
Secondary Outcome Measure Information:
Title
Adherence to cervical cancer screening (steps 1a, 2 and 3)
Description
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
Time Frame
Up to 20 months
Title
Text message status
Description
Proportion of received text messages, from those that were sent
Time Frame
Up to 20 months
Title
Automatic phone call status
Description
Proportion of delivered automatic phone calls, from those that were sent
Time Frame
Up to 20 months
Title
Organized screening
Description
Proportion of women undergoing cervical cancer screening in a private health institution who changed to organized cervical cancer screening
Time Frame
Up to 20 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firmino DB Machado, MD
Organizational Affiliation
EPIUnit - Instituto de Saúde Pública da Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACeS Porto Ocidental
City
Porto
ZIP/Postal Code
4100
Country
Portugal
Facility Name
ACeS Marão e Douro Norte
City
Vila Real
ZIP/Postal Code
5000
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32779730
Citation
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.
Results Reference
derived
PubMed Identifier
30936001
Citation
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.
Results Reference
derived
PubMed Identifier
29894717
Citation
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.
Results Reference
derived
PubMed Identifier
28982833
Citation
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.
Results Reference
derived

Learn more about this trial

Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer

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