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Messages For Your Health: A Cancer Screening Prevention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376023
Recruitment Status : Unknown
Verified February 2017 by Javiera Martínez, Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : March 3, 2015
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Centro de Salud Familiar El Roble
Information provided by (Responsible Party):
Javiera Martínez, Pontificia Universidad Catolica de Chile

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Other: mHealth Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of Mobile Technologies for the Prevention of Cervical Cancer in Santiago, Chile: A Randomized Controlled Trial.
Actual Study Start Date : February 22, 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: mHealth
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
Text and voice messages sent to study participants reminding them to schedule a PAP smear.

No Intervention: No mHealth
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.



Primary Outcome Measures :
  1. Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. [ Time Frame: 6 months after randomization of study ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376023


Contacts
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Contact: Javiera Martínez, MD, MPH (56) 23548688 jmarting@med.puc.cl

Locations
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Chile
CESFAM El Roble Recruiting
Santiago, RM, Chile, 8820814
Contact: Francis Ciampi, Nurse    225435479    cesfam_elroble@yahoo.com   
CESFAM Juan Pablo II Recruiting
Santiago, RM, Chile, 8831695
Contact: Javiera Martinez-Gutierrez, MD, MPH    56224822410    jmarting@med.puc.cl   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Centro de Salud Familiar El Roble
Investigators
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Study Chair: Carmen Huerta Comisión Nacional de Investigación Científica y Tecnológica
Publications:
Human papillomavirus (HPV) and cervical cancer. (Updated 2014, November). Retrieved June 4, 2014, from http://www.who.int/mediacentre/factsheets/fs380
Defunciones y mortalidad por causas. (n.d.). Retrieved June 4, 2014, from http://www.deis.cl/?p=2541
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
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
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
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
Abonados Móviles [Mobile Subscribers]. (2015, January 9). Retrieved June 4, 2014, from http://www.subtel.gob.cl/informacion-estadistica-actualizada-e-historica4/informacion-estadistica4
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
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
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
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Javiera Martínez, Javiera Martínez MD, MPH, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02376023    
Other Study ID Numbers: CEC Med UC 14-213
FONIS ProyectoSA14ID0072 ( Other Grant/Funding Number: FONIS )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Javiera Martínez, Pontificia Universidad Catolica de Chile:
Cervical Cancer
Women
Latina
Chile
Text Message
Technology
Screening
Cancer Prevention
Health Disparities
Mobile Health
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases