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

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • 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 Locations

    • 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

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
Intervention / Treatment
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.
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.
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.
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

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

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.

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)

May 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

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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