- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02147080
A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults (UV4me)
Skin cancer is the most common cancer in the US, with over a million new cases diagnosed yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all age groups and also demonstrate increased exposure to natural and artificial UV radiation. Innovative interventions are needed to have an impact on skin cancer risk among young people. Unlike previous interventions, our skin cancer risk reduction intervention will be tailored (or personalized) to each individual participant and delivered via the Internet. The intervention will emphasize appearance concerns, which are known to be the primary motivation for UV exposure and lack of skin protection among young adults. This will be accomplished in part through the use of personalized facial images showing UV damage as well as computerized age progression demonstrations.
Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet designed to increase skin protection and decrease sun exposure behavior among young adults at moderate to high risk of developing skin cancer. Participants will be randomized to the tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.
Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family history of skin cancer), appearance consciousness, and past exposure and protective behaviors moderate intervention effects.
Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.
The goals of future research would be to enhance the tailored intervention, for example, by adding additional contacts or Internet technologies or features, disseminate the intervention, assess the longevity of effects, and/or adapt the tailored intervention for use with other cancer risk behaviors or at risk groups.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19111
- Fox Chase Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 18-25 years old
- Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)
Exclusion Criteria:
- History of skin cancer
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Tailored Intervention
Subject has access to the tailored web intervention
|
Tailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator
Altri nomi:
|
Comparatore attivo: Skin Cancer Foundation Website
Subject has access to the pre-existing Skin Cancer Foundation website
|
Current best practice website for skin cancer and prevention.
Includes information, images, news, and opportunities for advocacy.
|
Nessun intervento: Assessment Only Condition
Subjects will only complete assessments
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sun protection
Lasso di tempo: Follow-up 1 (3 weeks after baseline)
|
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
|
Follow-up 1 (3 weeks after baseline)
|
Sun protection
Lasso di tempo: Follow-up 2 (12 weeks after baseline)
|
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
|
Follow-up 2 (12 weeks after baseline)
|
Outdoor UV Exposure
Lasso di tempo: Follow-up 1 (3 weeks after baseline)
|
How many hours participants spend in the sun during peak daylight hours during the week
|
Follow-up 1 (3 weeks after baseline)
|
Outdoor UV exposure
Lasso di tempo: Follow-up 2 (12 weeks after baseline)
|
How many hours participants spend in the sun during peak daylight hours during the week
|
Follow-up 2 (12 weeks after baseline)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Indoor Tanning
Lasso di tempo: Follow-up 1 (3 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 1 (3 weeks after baseline)
|
Indoor Tanning
Lasso di tempo: Follow-up 2 (12 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Spray-on tan
Lasso di tempo: Follow-up 1 (3 weeks after baseline)
|
Number of spray-on tanning sessions in past month
|
Follow-up 1 (3 weeks after baseline)
|
Spray-on tan
Lasso di tempo: Follow-up 2 (12 weeks after baseline)
|
Number of spray-on tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
|
Sunless tanning creams
Lasso di tempo: Follow-up 1 (3 weeks after baseline)
|
Number of times sunless tanning cream has been used in the past month
|
Follow-up 1 (3 weeks after baseline)
|
Sunless tanning creams
Lasso di tempo: Follow-up 2 (12 weeks after baseline)
|
Number of times sunless tanning cream has been used in the past month
|
Follow-up 2 (12 weeks after baseline)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Carolyn Heckman, Ph.D, Fox Chase Cancer Center
Pubblicazioni e link utili
Pubblicazioni generali
- Heckman CJ, Handorf EA, Darlow SD, Ritterband LM, Manne SL. An online skin cancer risk-reduction intervention for young adults: Mechanisms of effects. Health Psychol. 2017 Mar;36(3):215-225. doi: 10.1037/hea0000420. Epub 2016 Nov 7.
- Heckman CJ, Darlow SD, Ritterband LM, Handorf EA, Manne SL. Efficacy of an Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Am J Prev Med. 2016 Jul;51(1):1-11. doi: 10.1016/j.amepre.2015.11.008. Epub 2016 Jan 22.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1R01CA154928-01 (Sovvenzione/contratto NIH degli Stati Uniti)
- 1R01CA154928 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Neoplasie cutanee
-
Aalborg UniversityCompletatoPrurito | Papaina | Skin Prick Test (SPT)Danimarca
-
Assistance Publique - Hôpitaux de ParisIltoo PharmaCompletatoRinocongiuntivite allergica al polline di betulla | Con un Skin Prick Test positivo al polline di betullaFrancia