NCT03178240

Brief Summary

Randomized trial looking at the effects of a behavioral photoaging software intervention on sunscreen use in the city of Itauna, Brazil.

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
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

June 2, 2017

Last Update Submit

June 2, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in prevalence of daily sunscreen use at six months

    The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to six months follow-up vs. in the control group from baseline to six months follow-up.

    6 months

  • Change in prevalence of daily sunscreen use at one months

    The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to one months follow-up vs. in the control group from baseline to one month follow-up.

    1 month

Study Arms (2)

Intervention

EXPERIMENTAL

45 minutes seminar on skin cancer prevention and UV-protection in general.

Behavioral: photoaging mirroring intervention

Control

NO INTERVENTION

The control croup takes part in the survey but does not receive an intervention.

Interventions

selfies of the students are photoaged showing them the consequences of their UV protection behavior on their own face

Intervention

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Visiting a secondary school in Brazil.

You may not qualify if:

  • Not visiting a secondary school in Brazil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Brinker TJ, Faria BL, de Faria OM, Klode J, Schadendorf D, Utikal JS, Mons U, Krieghoff-Henning E, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. Effect of a Face-Aging Mobile App-Based Intervention on Skin Cancer Protection Behavior in Secondary Schools in Brazil: A Cluster-Randomized Clinical Trial. JAMA Dermatol. 2020 Jul 1;156(7):737-745. doi: 10.1001/jamadermatol.2020.0511.

  • Brinker TJ, Faria BL, Gatzka M, de Faria OM, Heppt MV, Kirchberger MC, Schadendorf D, Nakamura Y, Buslaff F, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. A skin cancer prevention photoageing intervention for secondary schools in Brazil delivered by medical students: protocol for a randomised controlled trial. BMJ Open. 2018 Mar 6;8(3):e018299. doi: 10.1136/bmjopen-2017-018299.

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Titus J. Brinker, MD

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 6, 2017

Study Start

February 1, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share