- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07681791
Sun Safe Together: A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Melanoma is a leading cause of invasive cancer in teens and young adults aged 15-39. Most skin cancers are preventable with skin protection such as minimizing UVR exposure and wearing protective clothing and sunscreen. However, teens have low levels of sun protection. Thus, interventions targeting skin cancer risk reduction among teens are needed. The proposed Sun Safe Together (SST) intervention is a 12-week program consisting of sun safety and general health messages sent via multimedia messaging service (MMS) to teens and via a private Facebook group for parents.
This pilot trial is a single arm test of SST to determine:
- feasibility of enrolling parent-teen dyads
- engagement with/acceptability of the intervention via message views and acceptability ratings
- outcome data collection feasibility (i.e., daily diary, UVR exposure measured by UVR dosimeter)
- retention rates for teens and parents at 3 and 6 months
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New Jersey
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New Brunswick, New Jersey, États-Unis, 08901
- Recrutement
- Rutgers Cancer Institute
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Contact:
- Anna Mitarotondo, MS
- Numéro de téléphone: 732-514-2891
- E-mail: atm122@cinj.rutgers.edu
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Contact:
- Carolyn J. Heckman, PhD
- E-mail: teenhealthstudy@cinj.rutgers.edu
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Chercheur principal:
- Carolyn J. Heckman, PhD
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Chercheur principal:
- Katie A. Devine, PhD, MPH
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Parents and teens are participating as dyads, meaning both the parent and the teen need to be deemed eligible based on the criteria below to be able to participate.
Teens
- Must be ages 13-17 years
- Live with study parent equal to or greater than half time in US
- Have experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
- Have no personal history of melanoma or severe medical condition that prevents participation
- Have access to smartphone
- Speak and read English
Parents/Guardians
- Must be age 18 or older
- Live with a teen equal to or greater than half time in US
- Have a teen who had experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
- Have no personal history of melanoma or severe medical condition that prevents participation
- Have internet at home, a Facebook account, and be willing to use Facebook daily
- Have access to smartphone
- Speak and read English
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Teen MMS & Parent Facebook Intervention
|
Teens will receive MMS messages regarding sun safety behaviors and other general health issues for 12 weeks.
Parents of teenagers join a private Facebook group where membership, activities, and content are only viewable by invited members.
Content related to teen sun safety and general health will be posted for 12 weeks.
Research staff will moderate the group.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of recruitment
Délai: Baseline
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Feasibility of recruitment will be assessed by the proportion of eligible parent-teen dyads that enroll in the study
|
Baseline
|
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Acceptability of MMS intervention
Délai: Immediately after the intervention
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Items were adapted from the Acceptability of Intervention and Feasibility of Intervention Measures to obtain participant feedback about the acceptability, feasibility, ease of use, and impact of the intervention.
Individual items are rated on a 5-point likert scale from (1) Completely Disagree to (5) Completely Agree.
Higher scores indicated greater acceptability.
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Immediately after the intervention
|
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Engagement with MMS intervention
Délai: 3-months
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Proportion of messages viewed will be calculated to describe engagement.
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3-months
|
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Feasibility of Outcome Data Collection - 7-Day Diaries
Délai: Baseline, 3-months, 6-months
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Proportion of teens who complete 7-day diaries will be calculated.
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Baseline, 3-months, 6-months
|
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Feasibility of Outcome Data Collection - UVR Dosimeter
Délai: Baseline, 6 months
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Proportion of teens who return UVR dosimeter with usable data will be calculated.
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Baseline, 6 months
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Retention
Délai: 3-months, 6-months
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Proportion of enrolled teens who complete surveys at 3- and 6-months will be calculated.
|
3-months, 6-months
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Carolyn Heckman, PhD, Rutgers, The State University of New Jersey
- Chercheur principal: Katie A Devine, PhD, Rutgers, The State University of New Jersey
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Autres numéros d'identification d'étude
- Pro2025001264
- R34CA293237 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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