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Tobacco Cessation Training Program in Spanish-speaking Countries (FRUITFUL)

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. Identifier: NCT02718872
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : December 22, 2016
Instituto Oncológico del Oriente Boliviano
Instituto de Cancerología y Hospital Dr. Bernardo del Valle
Instituto de Enfermedades Respiratoiras INERAM Prof. Dr. Juan Max Boettner
Information provided by (Responsible Party):
Cristina Martínez Martínez, Institut Català d'Oncologia

Brief Summary:
This project is responsive to the identified gap of lack of tobacco cessation training programs in Latin American & Caribbean countries. Currently, smoking rates in the Latin American and Caribbean region are high, and previous surveys show that health professionals do not have enough skills to help smokers to quit. In consequence, in absence of trained health professionals, many smokers who visit health care services are under-treated. The Fruitful Project aims to adapt an original on-line course developed in Spain to the reality of the three Latin American countries (Bolivia, Guatemala and Paraguay) and disseminate evidence-based tobacco cessation interventions among health care professionals.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Behavioral: Tobacco cessation online training Not Applicable

Detailed Description:

Tobacco cessation training programs to treat tobacco dependence have measureable effects on patients' smoking. Tobacco consumption in low and middle income countries is increasing, but these countries usually lack measures to face the epidemic, including tobacco cessation training programs addressed to their health professionals and organizations.

Based on a previous online training program for hospital workers in Spain, the Fruitful Study aims are twofold:

  1. to adapt the course to the reality of 3 Spanish-speaking low and middle income countries (Bolivia, Guatemala, and Paraguay) and;
  2. to evaluate the effectiveness of the program among the participant hospitals and workers.

Investigators use a mixed methods design with a pre-post evaluation (quantitative approach) and in-depth interviews and focus groups (qualitative approach). The main outcomes will be:

  1. participants' attitudes, knowledge and behaviors before and after the training and
  2. the level of implementation of tobacco control policies within the hospitals before and after the training.

The theoretical framework for this project includes Card's adapting model and Roger's diffusion of innovations model.

This study will show whether it is possible to adapt an online course to the reality of developing countries. In addition, investigator will measure whether an online program will produce changes in tobacco control policies at the organizational level and increase the level of knowledge, attitudes and perception in tobacco cessation at participants' level.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development and Dissemination of a Tobacco Cessation Training Program for Healthcare Professionals in Spanish-speaking Countries
Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Tobacco cessation online training
Six hour smoking cessation online training addressed to health professionals from hospitals in 3 Latin American Countries. Participants are monitored by local coordinators that act as champions. They offer their assistance to log into the online platform, fill out the questionnaires, complete the evaluation, including other technical support. Participants' progress is monitored in real time onto the web platform. The project coordinator at ICO sends a report of the participants progress every other week to coordinators, and if necessary personal emails to motivate students to finish the course and complete the evaluations.
Behavioral: Tobacco cessation online training
The original course has been developed in the online platform e-oncologia ( based on the in-person courses offered during the last 10 years by the Tobacco Control Unit of the Catalan Institute of Oncology. The theoretical framework underpinning the training program is the Stages of Change Model and the curriculum was developed with the content of numerous meta-analysis and clinical practice guidelines. We created a fully referenced curriculum online, with feedback from an expert advisory group that oriented in the instructional design to ensure the course content was palatable for an online format and aligned with the learning objectives. The final curriculum content of the "Brief Intervention for Smoking Cessation Training Program" is composed of 4 modules.

Primary Outcome Measures :
  1. Knowledge, attitudes, and behaviors of trainees [ Time Frame: six month ]
    Trainers' attitudes, knowledge and behaviors will be assessed by using a questionnaire composed of 63-items. The web-site delivered questionnaire is e-mailed to the participants at baseline and 6 months after finishing the training. The questionnaire takes 30-40 minutes to complete. It has been designed according to Sheffer work. The questionnaire gathers information about the provider gender, tobacco use history, previous tobacco cessation education, level of proactivity addressing tobacco use, and perceived success in helping patients stop using tobacco.

Secondary Outcome Measures :
  1. Compliance with tobacco control policies in hospitals [ Time Frame: one year ]
    Score in the self-audit questionnaire,

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Health professionals of the participating centers

Exclusion Criteria:

  • No exclusion criteria

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 identifier (NCT number): NCT02718872

Sponsors and Collaborators
Institut Català d'Oncologia
Instituto Oncológico del Oriente Boliviano
Instituto de Cancerología y Hospital Dr. Bernardo del Valle
Instituto de Enfermedades Respiratoiras INERAM Prof. Dr. Juan Max Boettner
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Principal Investigator: Crisitna Martínez, PhD Institut Català d'Oncologia - Institut d'Investigació Biomèdica de Bellvitge - Universitat de Barcelona ICO-IDIBELL-UB
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cristina Martínez Martínez, Doctor, Institut Català d'Oncologia Identifier: NCT02718872    
Other Study ID Numbers: FRUITFUL GB-13520139
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: NO plans for data sharing