- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965608
- Original Trial
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
Not yet recruiting
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
- Name: Diogo G Bugano, MD
- Phone Number: +551121511233
- Email: diogo.gomes@einstein.br
Study Locations
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-
GO
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Aparecida de Goiania, GO, Brazil
- HMAP - Hospital Municipal de Aparecida de Goiânia
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Contact:
- Mayler O. N. de Santos, MD
- Phone Number: +55 62 3878-5100
- Email: mayler.santos@einstein.br
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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.
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|
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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.
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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.
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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.
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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.
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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.
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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.
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Up to 2 weeks after WhatsApp intervention completion
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Acceptability of the WhatsApp-Based Intervention
Time Frame: Up to 2 weeks after WhatsApp intervention completion
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Mean acceptability score from participant survey (Likert scale 1-5) evaluating message usefulness and clarity.
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Up to 2 weeks after WhatsApp intervention completion
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Appropriateness of the WhatsApp-Based Intervention
Time Frame: Up to 2 weeks after WhatsApp intervention completion
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Proportion of participants who indicate willingness to receive similar messages in the future (Yes/No).
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Up to 2 weeks after WhatsApp intervention completion
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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
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Baseline and final assessment (up to 2 weeks after intervention)
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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)
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Proportion of healthcare professionals reporting intention to integrate cancer prevention counseling into clinical practice, assessed via the KAP questionnaire.
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Baseline, post-workshop (up to 2 weeks), and final assessment (up to 2 weeks after intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Strasser-Weippl K, Chavarri-Guerra Y, Villarreal-Garza C, Bychkovsky BL, Debiasi M, Liedke PE, Soto-Perez-de-Celis E, Dizon D, Cazap E, de Lima Lopes G Jr, Touya D, Nunes JS, St Louis J, Vail C, Bukowski A, Ramos-Elias P, Unger-Saldana K, Brandao DF, Ferreyra ME, Luciani S, Nogueira-Rodrigues A, de Carvalho Calabrich AF, Del Carmen MG, Rauh-Hain JA, Schmeler K, Sala R, Goss PE. Progress and remaining challenges for cancer control in Latin America and the Caribbean. Lancet Oncol. 2015 Oct;16(14):1405-38. doi: 10.1016/S1470-2045(15)00218-1.
- Delucchi KL, Tajima B, Guydish J. Development of the Smoking Knowledge, Attitudes, and Practices (S-KAP) Instrument. J Drug Issues. 2009 Mar;39(2):347-364. doi: 10.1177/002204260903900207.
- Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217-24. doi: 10.31887/DCNS.2011.13.2/npatsopoulos.
- Busetto L, Wick W, Gumbinger C. How to use and assess qualitative research methods. Neurol Res Pract. 2020 May 27;2:14. doi: 10.1186/s42466-020-00059-z. eCollection 2020.
- Espina C, Feliu A, Gonzalez Vingut A, Liddle T, Jimenez-Garcia C, Olaya-Caro I, Perula-De-Torres LA. Population-Based Cancer Prevention Education Intervention Through mHealth: A Randomized Controlled Trial. J Med Syst. 2024 Jan 9;48(1):9. doi: 10.1007/s10916-023-02026-y.
- Nardi A, Mitrova S, Angelici L, De Gregorio CG, Biliotti D, De Vito C, Vecchi S, Davoli M, Agabiti N, Acampora A. Developing a Questionnaire Evaluating Knowledge, Attitudes and Behaviors on Audit & Feedback among General Practitioners: A Mixed Methods Study. Healthcare (Basel). 2023 Apr 24;11(9):1211. doi: 10.3390/healthcare11091211.
- Espina C, Feliu A, Maza M, Almonte M, Ferreccio C, Finck C, Herrero R, Dommarco JR, de Almeida LM, Arrossi S, Garcia PJ, Garmendia ML, Mohar A, Murillo R, Santamaria J, Tortolero-Luna G, Cazap E, Gabriel OO, Paonessa D, Zoss JW, Luciani S, Carvalho A, Schuz J; Working Groups of Scientific Experts. Latin America and the Caribbean Code Against Cancer 1st Edition: 17 cancer prevention recommendations to the public and to policy-makers (World Code Against Cancer Framework). Cancer Epidemiol. 2023 Oct;86 Suppl 1:102402. doi: 10.1016/j.canep.2023.102402. Epub 2023 Oct 16.
- Fleary SA, Paasche-Orlow MK, Joseph P, Freund KM. The Relationship Between Health Literacy, Cancer Prevention Beliefs, and Cancer Prevention Behaviors. J Cancer Educ. 2019 Oct;34(5):958-965. doi: 10.1007/s13187-018-1400-2.
- Morris NS, Field TS, Wagner JL, Cutrona SL, Roblin DW, Gaglio B, Williams AE, Han PJ, Costanza ME, Mazor KM. The association between health literacy and cancer-related attitudes, behaviors, and knowledge. J Health Commun. 2013;18 Suppl 1(Suppl 1):223-41. doi: 10.1080/10810730.2013.825667.
- Barrios CH, Werutsky G, Mohar A, Ferrigno AS, Muller BG, Bychkovsky BL, Castro E CJ, Uribe CJ, Villarreal-Garza C, Soto-Perez-de-Celis E, Gutierrez-Delgado F, Kim JS, Ismael J, Delgado L, Santini LA, Teich N, Chavez PC, Liedke PER, Exman P, Barroso-Sousa R, Stefani SD, Caceres SAB, Rebelatto TF, Pastrana T, Chavarri-Guerra Y, Vargas Y, Cazap E. Cancer control in Latin America and the Caribbean: recent advances and opportunities to move forward. Lancet Oncol. 2021 Nov;22(11):e474-e487. doi: 10.1016/S1470-2045(21)00492-7.
- Rezende LFM, Lee DH, Louzada MLDC, Song M, Giovannucci E, Eluf-Neto J. Proportion of cancer cases and deaths attributable to lifestyle risk factors in Brazil. Cancer Epidemiol. 2019 Apr;59:148-157. doi: 10.1016/j.canep.2019.01.021. Epub 2019 Feb 14.
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
Keywords
Other Study ID 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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