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Protokoll zur Entwicklung und Prüfung der Wirksamkeit eines Schulungsprogramms zur Selbstuntersuchung auf Hautkrebs: Eine randomisierte kontrollierte Studie

23. September 2026 aktualisiert von: National University Hospital, Singapore

Protokoll für die Entwicklung und Prüfung der Wirksamkeit eines Schulungsprogramms zur Selbsterkennung von Hautkrebs: Eine randomisierte kontrollierte 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

280

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

16 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: 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.
Verhalten: Wait-list Control

Participants in the control group will gain access to the intervention websites after the 4-month questionnaire is completed.
Experimental: 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.
Verhalten: Skin Cancer Self-Detection Educational Program with gain-framing

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.
Experimental: 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.
Verhalten: Skin Cancer Self-Detection Educational Program with loss-framing

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in competency scores
Zeitfenster: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention

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

  1. Both intervention arms with the control group at 4 months, and
  2. Between gain framed and loss framed intervention arms at 4 months
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Knowledge of skin cancer, sun protection and skin self-examination
Zeitfenster: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention

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
Attitudes toward carrying out sun protection behaviours
Zeitfenster: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention

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
Subjective norms, which refer to participants' perception of whether significant individuals in their lives would support sun protection behaviours
Zeitfenster: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention

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
Behavioural outcomes (sun protection behaviour and skin self-examination)
Zeitfenster: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention

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
Intentions of participants toward carrying out skin cancer risk prevention strategies
Zeitfenster: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National University Hospital, Singapore

Ermittler

  • Hauptermittler: Ellie Choi, MBBS, National University Hospital, Singapore

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

19. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. November 2025

Zuerst gepostet (Tatsächlich)

25. November 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. September 2026

Zuletzt verifiziert

1. Oktober 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2024/00074

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

IPD shared includes de-identified demographics and measures.

IPD-Sharing-Zeitrahmen

IPD and supporting information will be available from the time of publication and for four years thereafter.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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