Plain English Summary
Background and study aims
The overall number of cancer cases is increasing and, therefore, strengthening cancer prevention has become a priority. The recommendations for primary prevention include advices, such as: not smoking, following a healthy diet, doing daily physical exercise or avoiding overweight, among others. Adolescence is a period of adoption and/or consolidation of health behaviors, and both school- and family-based interventions have proven effective to improve them. Furthermore, online and mobile phone educational interventions are encouraging. The main aims of the study are:
From a broad focus, to explore the capacity that the web and SMS provide to prevent cancer risk behaviors in adolescents and in their adult environment.
From a narrow focus, (a) to assess the diffusion capacity of an educational intervention based on new technologies, (b) to measure the beneficiary capture and (c) to describe cancer behavioral risk.
Who can participate?
Adolescents of Secondary Education who are aged between 12 and 16 years, and the adults of their environment (i.e. their relatives and teachers) who have voluntarily accepted to participate.
What does the study involve?
Participants will be randomly allocated to intervention and control group. The implementation and assessment of a complex online program, entitled Prevencanadol, supplemented with the delivery of SMS. The study factor is comprised of a tailor made website (www.alertagrumete.com) and of the delivery of SMS, which try to prevent cancer risk. A mixed group of (a) specialists in Preventive Medicine and (b) Secondary School teachers designed the educational contents (which are currently being taught at the schools by means of a specially prepared website) as well as the text of the SMS (related to the advantages of healthy behaviors and the skills to refuse invitations that can carry out risk behaviors).
What are the possible benefits and risks of participating?
Some benefits of participating in the study can be the following: a) to know the European Code against Cancer, whose recommendations are similar to those of other guidelines; b) to be influenced by the received information (using scientific methods of proven effectiveness) and consequently to follow the prevention advices; c) to integrate prevention activities in their daily lives, transversely. Thus, in general, the program will facilitate the meeting of several aims pointed out by the WHO for non communicable diseases. If the effectiveness of the educational intervention is confirmed, it will reduce the number of risk behaviours and their incorporation into the lifestyle of adolescents. Reducing the incidence of cancer is the expected result (if we achieve to control the behavioral risk factors included in the European Code against Cancer). Then, an improvement in quality of life and a reduction of the costs of cancer diagnosis and treatment will be the expected long term consequences. There are no evident risks for participants, but anticipating risks is very difficult due to this initiative's novelty, but other similar tools have not reported any problems for participants.
Where is the study run from?
The study is taking place in Spain and Mexico.
When is the study starting and how long is it expected to run for?
The study started at the beginning of 2010 and it is expected to run until the end of 2013 (incorporation of subjects). In 2014 we will perform a follow-up and an evaluation procedure.
Who is funding the study?
Ministerio de Ciencia e Innovación - Fondo de Investigación Sanitaria del Instituto de Salud Carlos III (Minisitry of Science and Innovation - Health Research Fund of the Institute of Health Carlos III)
Who is the main contact?
Dr. Alberto Lana Pérez
lanaalberto@uniovi.es
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FISS08PI080544
Study information
Scientific title
PREVENCANADOL project: impact of a website and some mobile phone SMS on behavioral risk of cancer in school population and its adult environment - a randomized controlled trial
Acronym
PREVENCANADOL
Study hypothesis
PREVENCANADOL [(PREVENCANADOL = PREVENtion - CANcer - ADOLescents)]
A multicomponent and complex educative intervention, based in the primary prevention advices of the European Code against Cancer and in the attitude-social influence-efficacy (ASE) Model, delivered by a website and supplemented with mobile phones, reduces cancer behavioral risk in adolescents and adults.
Ethics approval
Clinical Research Ethics Committee of Asturias Regional [Comité Ético de Investigación Clínica Regional del Principado de Asturias], 27/02/2009, ref: 19/09
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
http://www.alertagrumete.com/como-participar
Condition
Cancer risk behaviors
Intervention
This randomized controlled trial has two arms: subjects of the experimental group have free access to the whole sections of the website during one academic course and will receive around 40 mobile phone text messages (one per week). The website includes: 40 challenges or problems to be solved, which are adapted to the school curriculum and to cancer prevention, discussion forums, games, information and links, diet analysis and 40 educational videos.
Participants of the control group will have limited access to the described sections and they do not receive the messages.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Global cancer behavioral risk indicator
Secondary outcome measures
Cancer risk behaviors (smoking, diet, alcohol consumption, sun exposure, sedentarism and overweight)
Overall trial start date
01/10/2009
Overall trial end date
30/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Students of Secondary Education, aged between 12 and 16, either sex, who have voluntarily accepted to participate
2. To have access to the Internet
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Around 3,000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/10/2009
Recruitment end date
30/06/2013
Locations
Countries of recruitment
Mexico, Spain
Trial participating centre
Avda. Julián Clavería s/n.
Oviedo
33006
Spain
Sponsor information
Organisation
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Sponsor details
Calle Sinesio Delgado
6
Madrid
28019
Spain
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Instituto de Salud Carlos III (Ministerio de Ciencia e Innovación - España) (Spain) Number FISS08PI080544
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23594381
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24287124
Publication citations
-
Protocol
Lana A, del Valle MO, López S, Faya-Ornia G, López ML, Study protocol of a randomized controlled trial to improve cancer prevention behaviors in adolescents and adults using a web-based intervention supplemented with SMS., BMC Public Health, 2013, 13, 357, doi: 10.1186/1471-2458-13-357.
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Results
Lana A, Faya-Ornia G, López ML, Impact of a web-based intervention supplemented with text messages to improve cancer prevention behaviors among adolescents: results from a randomized controlled trial, Prev Med, 2014, 59, 54-59, doi: 10.1016/j.ypmed.2013.11.015.