Clinical trial NCT06965608: Feasibility Study to Actively Disseminate the Latin America and the Caribbean Code Against Cancer in Primary Healthcare Centers
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Latin America and the Caribbean Code Against Cancer (LAC Code)
Keywords: Health Literacy
Cancer Prevention
Health Services Research
Implementation Science
Latin America and the Caribbean Code Against Cancer (LAC Code)
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: International Agency for Research on Cancer
First posted: 2025-05-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the WhatsApp-Based Intervention
timeFrame: Up to 2 weeks after WhatsApp intervention completion
measure: Acceptability of the WhatsApp-Based Intervention
timeFrame: Up to 2 weeks after WhatsApp intervention completion
measure: Appropriateness of the WhatsApp-Based Intervention
timeFrame: Up to 2 weeks after WhatsApp intervention completion
Secondary outcomes:
Other outcomes:
measure: Receipt of Cancer Prevention Counseling Among the General Population (KAS Questionnaire)
timeFrame: Baseline and final assessment (up to 2 weeks after intervention)
measure: Intention to Provide Cancer Prevention Counseling Among Healthcare Professionals (KAP Questionnaire)
timeFrame: Baseline, post-workshop (up to 2 weeks), and final assessment (up to 2 weeks after intervention)
Locations:
city: Aparecida de Goiania
country: Brazil
facility: HMAP - Hospital Municipal de Aparecida de Goiânia
state: GO
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217-24. doi: 10.31887/DCNS.2011.13.2/npatsopoulos.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.