Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer

NCT03122275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2018-05-02

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03122275 on ClinicalTrials.gov