SMS Messaging for Invitation in the Cervical Cancer Screening Programme (CERCA-SMS)

May 2, 2022 updated by: Institut Català d'Oncologia

SMS Messaging for Invitation in the HPV-based Cervical Cancer Screening Programme in Catalonia (CERCA-SMS Study)

A study on two different methods of invitation to participate to the cervical cancer screening programme will be conducted within a demonstration project to switch from cytology-based screening to HPV-based screening using self-sampling delivered through the network of pharmacy offices among regular screening attendants in the Barcelona Metropolitana Sud Area, in Catalonia.

At the moment, eligible women are invited to participate to cervical cancer screening via a telephone call invitation explaining the new self-sampling method. Invitation via SMS containing a link to a webpage with information on most frequent questions might be an adequate alternative method that would save costs and workload on human resources.

The aim of this study is to assess the impact on cervical cancer screening participation of an invitation method based on text messaging (SMS).

The invitation method will be evaluated through an interventional trial, in which we will compare the invitation to cervical cancer screening using SMS versus a telephone call invitation explaining the new self-sampling method.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Main Hypothesis:

The use of direct SMS without an explanatory call for cervical cancer screening invitation is an acceptable option to invite women if the participation obtained is more than 70% and not less than 15% of the call (current practice).

Specific Hypothesis:

  • Participation in cervical cancer screening programme using SMS invitation is non-inferior to 70%.
  • Participation in cervical cancer screening programme using telephone call is non-inferior to 70%.
  • Participation using SMS invitation is non-inferior to participation using telephone call invitation, considering that an absolute difference less than 15% may not be clinically relevant.

Sample size calculation:

A one-sample non-inferiority test for calculating sample size was performed, assuming a participation rate of 80% using SMS invitation and 85% using telephone call invitation in the cervical cancer screening programme. To detect a participation rate using SMS or telephone call invitation non-inferior to 70%, with a margin of 5%, accepting an alpha risk of 0.025 and a beta risk of 0.2, and 5% of loses of follow-up, we will need 27 women in the telephone call group and 59 women in the SMS group. To observe this non-inferiority by age group (≤40 years, 41-54 years, ≥55 years), 27 and 59 women will be needed for each age group.

To compare both study arms, a two-sample non-inferiority test was performed assuming that using SMS messages to invite women to participate in cervical cancer screening programme will be 5% lower compared to participation when invitation is performed by a phone call (80% versus 85% respectively), although this difference will be non-inferior to 15-15.5%. Thus, if there is a true difference in favor of the telephone call group of 5%, assuming 5% of loses of follow-up, then 450 women will be required (225 in each arm) to be 80% sure that the upper limit of a one-sided 97.5% confidence interval will exclude a difference in favor of the SMS group of more than 15-15.5%.

Randomization procedure:

Women will be randomized in two study arms: intervention (SMS message invitation) and control (telephone call invitation). Randomization will be performed based on permuted blocks of 6 women to ensure equal distribution among age groups.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Catalunya, Spain
      • L'Hospitalet de Llobregat, Catalunya, Spain, Spain, 08908
        • Recruiting
        • Institut Catala D'oncologia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paula Peremiquel-Trillas, MD, MPH, PhDc
        • Principal Investigator:
          • Esther Roura Fornells, MPH, PhD
        • Sub-Investigator:
          • Laia Bruni Coccoz, MD, MPH, PhD
        • Sub-Investigator:
          • Clàudia Robles Hellín, MPH, PhD
        • Sub-Investigator:
          • Raquel Ibáñez, MPH, PhD
        • Sub-Investigator:
          • Laura Monfil, BSc
        • Sub-Investigator:
          • Maite Carvajal, RN
        • Sub-Investigator:
          • Rebeca Font

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Eligible women for cervical cancer screening aged 30 to 65 years of age.
  • Registered at the Health Care Database (RCA).

Exclusion Criteria:

  • Individuals without a mobile phone number registered at the RCA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental - Intervention
SMS invitation to participate in cervical cancer screening using HPV self-sampling.
Behavioral: SMS invitation
Behavioral: SMS to invite to cervical cancer screening using HPV self-sampling.
Active Comparator: Active Comparator - Usual Care
Phone call invitation to participate in cervical cancer screening using HPV self-sampling.
Behavioral: Phone call invitation
Behavioral: Phone call to invite to cervical cancer screening using HPV self-sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation in cervical cancer screening program
Time Frame: 12 weeks
Participation (no/yes) in cervical cancer screening program will be gathered prospectively 12 weeks after sending the screening invitation (day 0).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Català d'Oncologia

Investigators

  • Principal Investigator: Paula Peremiquel-Trillas, MD, MPH, PhDc, Institut Catala D'oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTC21-01
  • PR271/11 (Other Identifier: Independent Review Board Hospital Universitary de Bellvitge)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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