NCT02376023

Brief Summary

The purpose of this study is to evaluate the implementation and effectiveness of text messages as a means for improving adherence to cervical cancer screening.

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 17, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

February 22, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

February 17, 2015

Last Update Submit

February 7, 2017

Conditions

Cervical Cancer

Keywords

Cervical CancerWomenLatinaChileText MessageTechnologyScreeningCancer PreventionHealth DisparitiesMobile Health

Outcome Measures

Primary Outcomes (1)

  • Proportion of women who received a Pap smear within 6 months from the date when the study randomization began.

    The information will be collected from the cancer registration and monitoring database (CITOEXPERT/REVICAN), where Pap data of the population at the national level is registered. Investigators will also review medical records from participating patients at the two health centers. The data collection will take place 6 months after initial recruitment.

    6 months after randomization of study

Study Arms (2)

mHealth

EXPERIMENTAL

Women in the mHealth group will receive text and voice messages, in addition to their habitual care from the health clinic they attend. The messages will remind them to schedule a PAP smear, and will be sent for 1 year following enrollment in the study.

Other: mHealth

No mHealth

NO INTERVENTION

Women in the No mHealth group will not receive any text messages, and will only receive their habitual care from the health clinic they attend.

Interventions

mHealthOTHER

Text and voice messages sent to study participants reminding them to schedule a PAP smear.

mHealth

Eligibility Criteria

Age25 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must have and use a mobile phone
  • Enrolled at one of the following clinics: CESFAM El Roble or CESFAM Juan Pablo II.
  • Must not have had a Pap test within 3 years or more from recruitment

You may not qualify if:

  • Women who have ever had the diagnosis of cervical cancer.
  • Women with a mental or physical disability that inhibits them from understanding the implications of the study or being able to reach the health clinic for an exam.
  • Women that are considering relocating within the next year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CESFAM El Roble

Santiago, RM, 8820814, Chile

RECRUITING

CESFAM Juan Pablo II

Santiago, RM, 8831695, Chile

RECRUITING

Related Publications (17)

  • Human papillomavirus (HPV) and cervical cancer. (Updated 2014, November). Retrieved June 4, 2014, from http://www.who.int/mediacentre/factsheets/fs380

    BACKGROUND

  • Defunciones y mortalidad por causas. (n.d.). Retrieved June 4, 2014, from http://www.deis.cl/?p=2541

    BACKGROUND

  • Fica A. [Cancer of cervix in Chile. Too much vaccine amid a neglected Papanicolau]. Rev Chilena Infectol. 2014 Apr;31(2):196-203. doi: 10.4067/S0716-10182014000200010. Spanish.

    PMID: 24878908BACKGROUND

  • Martínez-Bejarano, R & Martínez-Salgado, C. La mortalidad por cáncer cérvico uterino y de mamá en Colombia y Mexico como expresión de las desigualdades socio-económicas y de genero. III Congreso de la Asociación Latinoamericana de Población, ALAP, Córdoba -Argentina, from 24-26 of September 2008. Retrieved June 4, 2014, from http://www.alapop.org/2009/images/DOCSFINAIS_PDF/ALAP _2008_FINAL_155.pdf

    BACKGROUND

  • Aylward, D., Leão, B., Curioso, W., & Cruz, F. (2010). Can You Heal Me Now? Potential (and Pitfalls) of mHealth. Americas Quarterly, 4(3), 88-95. Retrieved June 4, 2014, from http://www.americasquarterly.org/node/1699

    BACKGROUND

  • The World in 2014. ICT Facts and Figures. ITU World Telecommunications. Retrieved June 4, 2014, from http://www.itu.int/en/ITU-D/Statistics/Pages/facts/default.aspx

    BACKGROUND

  • Encuesta Nacional de Consumidores de Servicios de Telecomunicaciones. Subsecretaria de Telecomunicaciones 2014. http://www.subtel.gob.cl/component/search/?searchword=Encuesta%20Nacional&searchphrase=all&Itemid=101

    BACKGROUND

  • Abonados Móviles [Mobile Subscribers]. (2015, January 9). Retrieved June 4, 2014, from http://www.subtel.gob.cl/informacion-estadistica-actualizada-e-historica4/informacion-estadistica4

    BACKGROUND

  • MHealth: New Horizons for Health through Mobile Technologies. (2011). Global Observatory for EHealth Series, 3. Retrieved June 4, 2014, from http://www.who.int/goe/publications/goe_mhealth_web.pdf

    BACKGROUND

  • Green paper on mobile health (mHealth). (2010). European Commission. Retrieved June 4, 2014, from http://ec.europa.eu/digital-agenda/en/news/green-paper-mobile-health-mhealth

    BACKGROUND

  • Curioso WH, Mechael PN. Enhancing 'M-health' with south-to-south collaborations. Health Aff (Millwood). 2010 Feb;29(2):264-7. doi: 10.1377/hlthaff.2009.1057.

    PMID: 20348071BACKGROUND

  • Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for preventive health care. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007457. doi: 10.1002/14651858.CD007457.pub2.

    PMID: 23235643BACKGROUND

  • Curioso WH, Kepka D, Cabello R, Segura P, Kurth AE. Understanding the facilitators and barriers of antiretroviral adherence in Peru: a qualitative study. BMC Public Health. 2010 Jan 13;10:13. doi: 10.1186/1471-2458-10-13.

    PMID: 20070889BACKGROUND

  • Curioso, W., Gozzer, E., Valderrama, M., Rodriguez-Abad, J., Villena, J., Villena, A. Understanding the potential role of cell phones and the Internet to support care for diabetic patients and caregivers in Peru. AMIA 2009 Symposium Proceedings Page, 805. Retrieved June 4, 2014, from http://faculty.washington.edu/wcurioso/Curioso_Understanding_AMIA_2009.pdf

    BACKGROUND

  • Curioso, W., Gozzer, E., Valderrama, M., Rodriguez-Abad, J., Villena, J., Villena, A. (2009). Uso y percepciones hacia las tecnologías de información y comunicación en pacientes con diabetes en un hospital público del Perú. [Use and perceptions towards information and communication technologies in patients with diabetes in a Peruvian public hospital]. Rev Per Med Exp Sal Pub, 26(2), 161-67.

    BACKGROUND

  • 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: 32779730DERIVED

  • Momany MC, Martinez-Gutierrez J, Soto M, Capurro D, Ciampi F, Thompson B, Puschel K. Development of mobile technologies for the prevention of cervical cancer in Santiago, Chile study protocol: a randomized controlled trial. BMC Cancer. 2017 Dec 13;17(1):847. doi: 10.1186/s12885-017-3870-8.

    PMID: 29237420DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Carmen Huerta

    Comisión Nacional de Investigación Científica y Tecnológica

    STUDY CHAIR

Central Study Contacts

Javiera Martínez, MD, MPH

CONTACT

(56) 23548688jmarting@med.puc.cl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Javiera Martínez MD, MPH

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 3, 2015

Study Start

February 22, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CL(2)