NCT06145464

Brief Summary

The proposed project is a pilot study about the impact of different health literacy interventions, focused on preventing skin cancer, on the adhesion to protection strategies against ultraviolet (UV) radiation, observed in high school students, that will be implemented on Foz do Lizandro beach in the municipality of Mafra, Portugal. As a science project with citizenship and respecting the ethic principles of equity, inclusion and diversity, the study will involve the contribution and participation of institutional and community partners in diverse stages of the research study: design, field implementation, data collection and dissemination of results, as well as financial investment for the acquisition and installation of interventions on the beach, and recruitment of the target population.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 17, 2024

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 17, 2023

Last Update Submit

January 12, 2024

Conditions

Skin Cancer

Keywords

skin cancerpreventionadolescentsliteracycitizen science

Outcome Measures

Primary Outcomes (6)

  • Adhesion to the use of sunsail shadows

    Number of adolescents who use the sunsail shadows among all participant adolescents, in all groups of the study

    2 months (July + August 2024)

  • Adhesion to the use of sunscreen

    Number of adolescents who adhere to the use of sunscreen among all participant adolescents, in all groups of the study

    2 months (July + August 2024)

  • Adhesion to the use of infographic´s information

    Number of adolescents who read and use the information related to the promotion of healthy sun exposure behaviors, from the infographic located near the sunsail shadows, in all groups of the study

    2 months (July + August 2024)

  • Adhesion to the use of interventional strategies of sun protection at the beach

    Number of adolescents who use one, two or all of the three interventional strategies of sun protection implemented at the beach, in all groups of the study

    2 months (July + August 2024)

  • Skin absorption of UV radiation

    Number of adolescents who have a safe skin UV radiation absorption according to the interventional sun protection strategies used, in all groups of the study

    2 months (July + August 2024)

  • Impact of literacy sessions about the prevention of skin cancer on the amount of skin UV absorption in all interventional groups compared to the control group

    Amount of skin UV absorption per total number of participant adolescents in both interventional groups, in relation to the control group

    2 months (July + August 2024)

Study Arms (3)

Control

ACTIVE COMPARATOR

Adolescents will be recommended to use the sun protection interventions implemented on Foz do Lizandro beach (collective shadow, sun protector, and information about healthy behaviors of sun protection disposed in an infographic installed near the collective shadow), without a previous health literacy session about skin cancer prevention provided 15 days before the beginning of the use of the interventions on the beach.

Behavioral: Adhesion to the use of collective shadowBehavioral: Adhesion to the use of sun protectorBehavioral: Adhesion to the use of the information disposed in the infographic

Interventional EST SUP

EXPERIMENTAL

Adolescents will be recommended to use the sun protection interventions implemented on Foz do Lizandro beach (collective shadow, sun protector, and information about healthy behaviors of sun protection disposed in an infographic installed near the collective shadow), with a previous health literacy session about skin cancer prevention provided 15 days before the beginning of the use of the interventions on the beach by students on ongoing graduation at the University of Lisbon.

Behavioral: Adhesion to the use of collective shadowBehavioral: Adhesion to the use of sun protectorBehavioral: Adhesion to the use of the information disposed in the infographicBehavioral: Adhesion to the health literacy sessions in the interventional groups

Interventional FARMA

EXPERIMENTAL

Adolescents will be recommended to use the sun protection interventions implemented on Foz do Lizandro beach (collective shadow, sun protector, and information about healthy behaviors of sun protection disposed in an infographic installed near the collective shadow), with a previous health literacy session about skin cancer prevention provided 15 days before the beginning of the use of the interventions on the beach by community pharmacists who will be working on pharmacies located in Mafra.

Behavioral: Adhesion to the use of collective shadowBehavioral: Adhesion to the use of sun protectorBehavioral: Adhesion to the use of the information disposed in the infographicBehavioral: Adhesion to the health literacy sessions in the interventional groups

Interventions

Adhesion to the use of collective shadowBEHAVIORAL

Quantitative evaluation of the use of shadow provided by one or two collective fabric devices, with 6 per 3 metres of size, containing 100% UV blocking filters, that will be installed in the sand on Foz do Lizandro beach, according to the recommendations provided in all groups of the study.

ControlInterventional EST SUPInterventional FARMA
Adhesion to the use of sun protectorBEHAVIORAL

Quantitative evaluation of the use of sun protector according to the recommendations provided in all groups of the study.

ControlInterventional EST SUPInterventional FARMA
Adhesion to the use of the information disposed in the infographicBEHAVIORAL

Quantitative evaluation of the use of the information disposed in the infographic and provided in all groups of the study.

ControlInterventional EST SUPInterventional FARMA
Adhesion to the health literacy sessions in the interventional groupsBEHAVIORAL

Provision of health literacy sessions about skin cancer prevention by two different types of providers in the two interventional groups, 15 days before the use of sun protective interventions implemented at the beach

Interventional EST SUPInterventional FARMA

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • High school students at a public school in Mafra;
  • Age between 14 and 17 years old;
  • Residents in Mafra;
  • Fluent in the Portuguese language;
  • Regular users of beaches in the summer season

You may not qualify if:

  • Cognitive, hearing, visual and/or motor limitations that prevent the acquisition of knowledge and the use of sun protection strategies on the beach
  • Students at a higher education course in the area of health sciences;
  • Age between 18 and 25 years old;
  • Motivated to the field of health communication;
  • Preferably, with experience in research work during the course.
  • Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge
  • Professionally active in a community pharmacy in the region where the beach is located;
  • Preferably young people between 23 and 45 years old, regardless of professional experience;
  • With motivation for awareness-raising activities on disease prevention in communities;
  • Preferably, who have already carried out this type of awareness-raising actions among younger people on disease prevention or, specifically, on the prevention of skin cancer;
  • Affinity for the topic of skin cancer and its prevention.
  • Cognitive, hearing, visual and/or motor limitations that prevent the acquisition and transmission of knowledge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin NeoplasmsLiteracy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCommunicationBehavior

Study Officials

  • Magda Fonseca, Master

    RD-Portugal (Rare Diseases-Portugal)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Fonseca, Master

CONTACT

00351968027910magdapcfonseca81@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The target population will be single-blinded towards the professional activity of providers of health literacy sessions about the prevention of skin cancer in the two interventional groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Exploratory pilot study, with a quasi-experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

February 1, 2024

Primary Completion

August 31, 2024

Study Completion

September 30, 2024

Last Updated

January 17, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share