- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Tailored Intervention
Subject has access to the tailored web intervention
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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
Autres noms:
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Comparateur actif: Skin Cancer Foundation Website
Subject has access to the pre-existing Skin Cancer Foundation website
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Current best practice website for skin cancer and prevention.
Includes information, images, news, and opportunities for advocacy.
|
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Aucune intervention: Assessment Only Condition
Subjects will only complete assessments
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sun protection
Délai: 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)
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Sun protection
Délai: Follow-up 2 (12 weeks after baseline)
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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)
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Outdoor UV Exposure
Délai: Follow-up 1 (3 weeks after baseline)
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How many hours participants spend in the sun during peak daylight hours during the week
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Follow-up 1 (3 weeks after baseline)
|
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Outdoor UV exposure
Délai: Follow-up 2 (12 weeks after baseline)
|
How many hours participants spend in the sun during peak daylight hours during the week
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Follow-up 2 (12 weeks after baseline)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Indoor Tanning
Délai: Follow-up 1 (3 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 1 (3 weeks after baseline)
|
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Indoor Tanning
Délai: Follow-up 2 (12 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Spray-on tan
Délai: Follow-up 1 (3 weeks after baseline)
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Number of spray-on tanning sessions in past month
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Follow-up 1 (3 weeks after baseline)
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Spray-on tan
Délai: Follow-up 2 (12 weeks after baseline)
|
Number of spray-on tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
|
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Sunless tanning creams
Délai: 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)
|
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Sunless tanning creams
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Carolyn Heckman, Ph.D, Fox Chase Cancer Center
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1R01CA154928-01 (Subvention/contrat des NIH des États-Unis)
- 1R01CA154928 (Subvention/contrat des NIH des États-Unis)
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