Protokol pro vývoj a testování účinnosti vzdělávacího programu pro samovyšetření kožního nádoru: Randomizovaná kontrolovaná studie
Protokol pro vývoj a testování účinnosti vzdělávacího programu pro samovyšetření rakoviny kůže: Randomizovaná kontrolovaná studie
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ellie Choi, MBBS
- Telefonní číslo: 65 6908 2222
- E-mail: dermresearchec@nuhs.edu.sg
Studijní místa
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Singapore, Singapur, 609783
- Nábor
- National University Hospital
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Kontakt:
- Ellie Choi
- Telefonní číslo: 67795555
- E-mail: dermresearchec@nuhs.edu.sg
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: 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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Experimentální: 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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Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in competency scores
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Knowledge of skin cancer, sun protection and skin self-examination
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Ellie Choi, MBBS, National University Hospital, Singapore
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2024/00074
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
IPD shared includes de-identified demographics and measures.
Časový rámec sdílení IPD
IPD and supporting information will be available from the time of publication and for four years thereafter.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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