Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer

NCT03122275 | Completed

• 1 other identifier: EPIUnit_SCANCC_2017
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 2

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.

Conditions

Mass Screening; Early Detection of Cancer; Uterine Cervical Neoplasm; Text Message; Reminder Systems

Keywords

Adherence; Directive Counseling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adherence to cervical cancer screening (steps 1a, 2 and 3)

  Up to 20 months

• Text message status

  Up to 20 months

• Automatic phone call status

  Up to 20 months

• Organized screening

  Up to 20 months

Study Arms (2)

Stepwise intervention

EXPERIMENTAL

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); Other: Customized automatic phone call invitation (Step 1b); Other: Secretary phone call (Step 2); Other: Health professional face-to-face appointment (Step 3)

Written Letter

ACTIVE COMPARATOR

Comparator will be the standard of care of invitation to cervical cancer screening: written letter

Other: Written Letter

Interventions

Customized text message invitation ( Step 1a) OTHER

Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening

Stepwise intervention

Customized automatic phone call invitation (Step 1b) OTHER

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

Stepwise intervention

Secretary phone call (Step 2) OTHER

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)

Stepwise intervention

Health professional face-to-face appointment (Step 3) OTHER

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.

Stepwise intervention

Written Letter OTHER

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.

Written Letter

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unavailability of mobile phone number

Sponsors & Collaborators

• João Firmino Domingues Barbosa Machado: lead
• Universidade do Porto: collaborator

Study Sites (2)

ACeS Porto Ocidental

Porto, 4100, Portugal

Location

ACeS Marão e Douro Norte

Vila Real, 5000, Portugal

Location

Related Publications (4)

• 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.

  PMID: 32779730 DERIVED

• 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.

  PMID: 30936001 DERIVED

• 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.

  PMID: 29894717 DERIVED

• 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.

  PMID: 28982833 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Firmino DB Machado, MD

  EPIUnit - Instituto de Saúde Pública da Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 20, 2017
• Study Start: April 27, 2017
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)