- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07247123
피부암 자가 검출 교육 프로그램 개발 및 효과 검증을 위한 연구 프로토콜: 무작위 대조군 임상시험
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
상태
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
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ellie Choi, MBBS
- 전화번호: 65 6908 2222
- 이메일: dermresearchec@nuhs.edu.sg
연구 장소
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Singapore, 싱가포르, 609783
- 모병
- National University Hospital
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연락하다:
- Ellie Choi
- 전화번호: 67795555
- 이메일: dermresearchec@nuhs.edu.sg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
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
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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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. |
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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. |
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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 |
|---|---|---|
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Change in competency scores
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knowledge of skin cancer, sun protection and skin self-examination
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Ellie Choi, MBBS, National University Hospital, Singapore
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024/00074
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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
미국 FDA 규제 기기 제품 연구
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. .