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

December 21, 2016 updated by: Cristina Martínez Martínez, Institut Català d'Oncologia

Development and Dissemination of a Tobacco Cessation Training Program for Healthcare Professionals in Spanish-speaking Countries

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health professionals of the participating centers

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 (http://www.e-oncologia.org/en/) 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
six month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compliance with tobacco control policies in hospitals
Time Frame: one year
Score in the self-audit questionnaire,
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Català d'Oncologia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto Oncológico del Oriente Boliviano
Instituto de Cancerología y Hospital Dr. Bernardo del Valle
Instituto de Enfermedades Respiratoiras INERAM Prof. Dr. Juan Max Boettner

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Crisitna Martínez, PhD, Institut Català d'Oncologia - Institut d'Investigació Biomèdica de Bellvitge - Universitat de Barcelona ICO-IDIBELL-UB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FRUITFUL GB-13520139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

NO plans for data sharing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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