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피부암 자가 검출 교육 프로그램 개발 및 효과 검증을 위한 연구 프로토콜: 무작위 대조군 임상시험

2026년 9월 23일 업데이트: National University Hospital, Singapore

피부암 자가 발견 교육 프로그램의 개발 및 효과성 검증을 위한 프로토콜: 무작위 대조 시험

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

280

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

16년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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.

실험적: 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.

실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in competency scores
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Knowledge of skin cancer, sun protection and skin self-examination
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Ellie Choi, MBBS, National University Hospital, Singapore

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 15일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2025년 11월 19일

QC 기준을 충족하는 최초 제출

2025년 11월 19일

처음 게시됨 (실제)

2025년 11월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 23일

마지막으로 확인됨

2025년 10월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

IPD shared includes de-identified demographics and measures.

IPD 공유 기간

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

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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