Feasibility Study to Actively Disseminate the Latin America and the Caribbean Code Against Cancer in Primary Healthcare Centers (FLACC-Brazil)

May 2, 2025 updated by: Hospital Israelita Albert Einstein

Feasibility Study to Actively Disseminate the Latin America and the Caribbean Code Against Cancer in Primary Healthcare Centers in Aparecida de Goiania (Brazil) - FLACC-Brazil

Phase II non-randomized four-arm study (before/after pragmatic trial) that will test 2 different implementation strategies either combined or separately for the dissemination of the Latin America and the Caribbean Code Against Cancer within four different primary healthcare units in Aparecida de Goiânia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
1200

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • GO
      • Aparecida de Goiania, GO, Brazil
        • HMAP - Hospital Municipal de Aparecida de Goiânia
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults (≥18 years old)
  • Registered at a participating primary healthcare center (UBS) in Aparecida de Goiânia
  • Healthcare professionals with at least three months of employment at a participating UBS
  • Ability to provide informed consent

Exclusion Criteria:

- Prior diagnosis of any cancer or currently undergoing cancer treatment

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
No Intervention: Control Group
Participants in this arm will receive no intervention during the study period. They will complete baseline and follow-up assessments to evaluate changes in cancer prevention literacy and health services-related outcomes over time, serving as a comparison for the intervention arms.
Experimental: G1: WhatsApp Messaging Intervention - General Population
Participants in this arm will receive structured cancer prevention messages via WhatsApp over a four-week period. The messages will cover key recommendations from the Latin America and the Caribbean Code Against Cancer (LAC Code), focusing on actionable steps to reduce cancer risk. Healthcare professionals (HCPs) assigned to this group will not receive any training.
Behavioral: WhatsApp-Based Cancer Prevention Messaging
Participants in this group will receive a structured series of WhatsApp messages containing evidence-based cancer prevention recommendations from the Latin America and Caribbean Code Against Cancer (LAC Code). Messages will be delivered over four weeks, 3 times a week, covering key topics such as smoking cessation, healthy diet, physical activity, and regular screening. Engagement metrics will be tracked to assess feasibility and adherence.
Experimental: G2: Online Workshop for Healthcare Professionals (HCP)
Description: Healthcare professionals (HCPs) in this arm will participate in an online, self-paced workshop designed to enhance their knowledge and communication skills related to cancer prevention. The workshop will provide evidence-based training on discussing cancer risk factors and prevention strategies with patients, aligning with the LAC Code recommendations. General population participants assigned to this group will not receive WhatsApp messages.
Behavioral: Online Cancer Prevention Workshop for Healthcare Professionals
Healthcare professionals assigned to this group will participate in an online workshop designed to improve their knowledge of the LAC Code and communication strategies for cancer prevention counseling. The workshop includes recorded lectures, interactive modules, and knowledge assessments. Completion rates and participant satisfaction will be measured.
Experimental: G3: Combined Intervention (WhatsApp + Workshop)
This arm will integrate both intervention strategies. General population participants will receive WhatsApp messages with cancer prevention recommendations, while healthcare professionals will complete the online workshop. This combined approach aims to assess whether reinforcing cancer prevention messages at both the community and healthcare provider levels leads to improved outcomes in cancer prevention literacy and health services utilization.
Behavioral: Combined WhatsApp Messaging and Online Workshop
Participants in this group will receive both interventions: WhatsApp messages with cancer prevention recommendations and access to the online workshop. The intervention aims to assess whether a combined approach enhances adherence and impact. Engagement with both interventions will be monitored.

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
Feasibility of the WhatsApp-Based Intervention
Time Frame: Up to 2 weeks after WhatsApp intervention completion
Number of participants who report having read at least one WhatsApp message.
Up to 2 weeks after WhatsApp intervention completion
Acceptability of the WhatsApp-Based Intervention
Time Frame: Up to 2 weeks after WhatsApp intervention completion
Mean acceptability score from participant survey (Likert scale 1-5) evaluating message usefulness and clarity.
Up to 2 weeks after WhatsApp intervention completion
Appropriateness of the WhatsApp-Based Intervention
Time Frame: Up to 2 weeks after WhatsApp intervention completion
Proportion of participants who indicate willingness to receive similar messages in the future (Yes/No).
Up to 2 weeks after WhatsApp intervention completion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Receipt of Cancer Prevention Counseling Among the General Population (KAS Questionnaire)
Time Frame: Baseline and final assessment (up to 2 weeks after intervention)
Proportion of general population participants reporting receipt of at least one type of cancer prevention counseling (e.g., smoking cessation, diet, physical activity) as assessed by the KAS questionnaire
Baseline and final assessment (up to 2 weeks after intervention)
Intention to Provide Cancer Prevention Counseling Among Healthcare Professionals (KAP Questionnaire)
Time Frame: Baseline, post-workshop (up to 2 weeks), and final assessment (up to 2 weeks after intervention)
Proportion of healthcare professionals reporting intention to integrate cancer prevention counseling into clinical practice, assessed via the KAP questionnaire.
Baseline, post-workshop (up to 2 weeks), and final assessment (up to 2 weeks after intervention)

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.
Hospital Israelita Albert Einstein

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.
International Agency for Research on Cancer

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

Helpful Links

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 (Estimated)

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.
May 1, 2025

Primary Completion (Estimated)

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.
October 1, 2025

Study Completion (Estimated)

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.
November 1, 2025

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).
March 20, 2025

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.
May 2, 2025

First Posted (Actual)

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.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

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.
May 11, 2025

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.
May 2, 2025

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.
April 1, 2025

More Information

Terms related to this study

Keywords

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.
  • LACCODE - FLACC-Brazil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy considerations and institutional policies governing data access. However, aggregated and de-identified study results will be shared through peer-reviewed publications and conference presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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