Protocole pour le développement et l'évaluation de l'efficacité d'un programme éducatif d'autodétection du cancer de la peau : un essai contrôlé randomisé
Protocole pour le développement et l'évaluation de l'efficacité d'un programme éducatif d'auto-détection du cancer de la peau : un essai contrôlé randomisé
Skin cancer is a significant public health concern, even in an Asian society like Singapore where it ranks among the top 10 cancers. This RCT tests the effectiveness of a skin cancer educational intervention to improve skin cancer outcomes among skin-of-color individuals, including the effects of gain versus loss framing.
Aperçu de l'étude
Statut
Description détaillée
Reducing skin cancer related morbidity and mortality involves two broad domains; (1) Identification and early detection of skin cancers and (2) Awareness and behavioral change to reduce modifiable risk factors like UV exposure. Regular self-examination and public education have been shown in RCTs to improve knowledge and identification of skin cancers. However most of these existing studies and the tools they utilise rely on Western-centric photographs and messaging, such as the 'ABCDE rule' for superficial spreading and nodular melanoma. These neglect skin cancers far more common in skin of colour population such as acral lentiginous melanomas, pigmented basal cell and squamous cell carcinomas.
In addition to improving detection, effective behavioural change strategies are needed to encourage protective practices such as regular sunscreen use. Message framing has gained interest as a behavioral change technique: gain-framed messages emphasize the benefits of adopting a behavior, while loss-framed messages highlight the negative consequences of not doing so. Although message framing is widely used in health communication, evidence of its effectiveness in promoting skin cancer-related behaviors is unclear.
Effectiveness of our proposed intervention can help to increase adoption of sun protective behaviours, improve detection rates of skin cancer and allow earlier medical intervention, hence reducing morbidity and mortality of skin cancer.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ellie Choi, MBBS
- Numéro de téléphone: 65 6908 2222
- E-mail: dermresearchec@nuhs.edu.sg
Lieux d'étude
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Singapore, Singapour, 609783
- Recrutement
- National University Hospital
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Contact:
- Ellie Choi
- Numéro de téléphone: 67795555
- E-mail: dermresearchec@nuhs.edu.sg
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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:
- Individuals aged 16 and above
- Able to read and converse in English
- Able to provide informed consent
- Having the ability to use and interact with a web server or application.
Exclusion Criteria:
- Individuals who have cognitive impairment or decline to participate. There will be no exclusion criteria based on a previous history of skin cancer.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Control
Participants will fill up a baseline competency examination and questionnaire, and another at the 4 month mark. Access to the intervention for control group participants will only be provided after the 4-month questionnaire is completed. |
Participants in the control group will gain access to the intervention websites after the 4-month questionnaire is completed. |
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Expérimental: Intervention with gain framing
Participants will fill up a baseline competency examination and questionnaire. Afterwards, they will have access to a website with gain-framed messages emphasising benefits of adopting a behaviour. Thereafter, another competency questionnaire will be administered following completion of material. |
This educational website will feature gain-framing messages, emphasizing the benefits of adopting a behavior, utilising positive language and analogies. The interventional domains are (1) Education on skin cancer risk factors and epidemiology, (2) UV Protection Advice, (3) Skin Self-Examination Techniques and (4) Differentiating benign vs malignant skin conditions. |
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Expérimental: Intervention with loss framing
Participants will fill up a baseline competency examination and questionnaire. Afterwards, they will have access to a website with loss-framed messages highlighting consequences of failing to adopt a behaviour. Thereafter, another competency questionnaire will be administered following completion of material. |
This educational website will feature loss-framing messages, highlight the consequences of failing to adopt a behavior, utilising negative language and analogies. The interventional domains are (1) Education on skin cancer risk factors and epidemiology, (2) UV Protection Advice, (3) Skin Self-Examination Techniques and (4) Differentiating benign vs malignant skin conditions. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in competency scores
Délai: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Scores measured as percentage of correct questions answered. Range from 0% to 100% with higher score indicating higher ability to differentiate benign from malignant skin lesions. Change in scores will be calculated and compared between
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Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knowledge of skin cancer, sun protection and skin self-examination
Délai: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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20 Multiple Choice Questions created based on intervention website. Score range from 0 to 20, with a higher score indicate higher knowledge in risks of skin cancer, appropriate sunscreen use and features of cancerous lesions. |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Attitudes toward carrying out sun protection behaviours
Délai: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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6 questions graded on a 7-point Likert scale, with higher scores indicating better attitudes toward sun protection behaviours |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Subjective norms, which refer to participants' perception of whether significant individuals in their lives would support sun protection behaviours
Délai: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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7 questions graded on a 7-point Likert scale, with higher scores indicating a greater influence of others' perception on their sun protection behaviours |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Behavioural outcomes (sun protection behaviour and skin self-examination)
Délai: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Sun Exposure and Protection Index. 9 questions graded on a 5-point Likert scale assessing sun habits and sun protection behaviour. Lower scores indicate more optimal sun protection behaviours, with an additional adapted question. 11 additional questions regarding participants' sunscreen usage (e.g. type of sunscreen, frequency of reapplication), and skin-self examination, with a lower score indicating more optimal sun protection behaviours. |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Intentions of participants toward carrying out skin cancer risk prevention strategies
Délai: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Sun Exposure and Protection Index (6 questions with an additional adapted question). Each given response score (0-4) are summed, with scores ranging from 0-24, with higher score indicating a low propensity to increase sun protection. 2 additional questions regarding participants' intentions of conducting a skin-self examination. 7 point Likert Scale (1-7), with higher score indicating higher intentions of conducting a skin-self examination. |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ellie Choi, MBBS, National University Hospital, Singapore
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024/00074
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
IPD shared includes de-identified demographics and measures.
Délai de partage IPD
IPD and supporting information will be available from the time of publication and for four years thereafter.
Critères d'accès au partage IPD
Deidentified individual participant data supporting the findings of this study will be available from the corresponding author upon reasonable request. Access will be granted on a case-by-case basis following review and approval of a data access proposal and completion of a data sharing agreement.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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