Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer
NCT03122275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1220
Last updated 2018-05-02
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.
Conditions
- Mass Screening
- Early Detection of Cancer
- Uterine Cervical Neoplasm
- Text Message
- Reminder Systems
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Universidade do Porto
collaborator OTHER -
João Firmino Domingues Barbosa Machado
lead OTHER
Principal Investigators
-
Firmino DB Machado, MD · EPIUnit - Instituto de Saúde Pública da Universidade do Porto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-04-27
- Primary Completion
- 2018-04-27
- Completion
- 2018-04-27
Countries
- Portugal
Study Locations
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