NCT05362669

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 2, 2022

Last Update Submit

May 2, 2022

Conditions

Keywords

ScreeningSelf-sampling

Outcome Measures

Primary Outcomes (1)

  • Participation in cervical cancer screening program

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

    12 weeks

Study Arms (2)

Experimental - Intervention

EXPERIMENTAL

SMS invitation to participate in cervical cancer screening using HPV self-sampling.

Behavioral: SMS invitation

Active Comparator - Usual Care

ACTIVE COMPARATOR

Phone call invitation to participate in cervical cancer screening using HPV self-sampling.

Behavioral: Phone call invitation

Interventions

SMS invitationBEHAVIORAL

Behavioral: SMS to invite to cervical cancer screening using HPV self-sampling.

Experimental - Intervention

Behavioral: Phone call to invite to cervical cancer screening using HPV self-sampling.

Active Comparator - Usual Care

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women participate in cervical cancer screening programme
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Catalunya, Spain, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Paula Peremiquel-Trillas, MD, MPH, PhDc

    Institut Català d'Oncologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Peremiquel-Trillas, MD, MPH, PhDc

CONTACT

Esther Roura Fornells, MPH, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Invitation to cervical cancer screening using SMS compared to telephone call invitation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

November 8, 2021

Primary Completion

May 31, 2022

Study Completion

December 31, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations