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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
Sponsor:
Collaborator:
Universidade do Porto
Information provided by (Responsible Party):
João Firmino Domingues Barbosa Machado, Universidade do Porto

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Text message status [ Time Frame: Up to 20 months ]
    Proportion of received text messages, from those that were sent

  3. Automatic phone call status [ Time Frame: Up to 20 months ]
    Proportion of delivered automatic phone calls, from those that were sent

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Portugal
ACeS Porto Ocidental
Porto, Portugal, 4100
ACeS Marão e Douro Norte
Vila Real, Portugal, 5000
Sponsors and Collaborators
João Firmino Domingues Barbosa Machado
Universidade do Porto
Investigators
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Principal Investigator: Firmino DB Machado, MD EPIUnit - Instituto de Saúde Pública da Universidade do Porto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: João Firmino Domingues Barbosa Machado, Principal Investigator, Universidade do Porto
ClinicalTrials.gov Identifier: NCT03122275    
Other Study ID Numbers: EPIUnit_SCANCC_2017
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by João Firmino Domingues Barbosa Machado, Universidade do Porto:
Adherence
Directive Counseling
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases