- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07247123
Developing and Testing the Effectiveness of a Skin Cancer Self-Detection Educational Program
Protocol for Developing and Testing the Effectiveness of a Skin Cancer Self-Detection Educational Program: A Randomised Controlled Trial
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ellie Choi, MBBS
- Phone Number: 65 6908 2222
- Email: dermatology@nuhs.edu.sg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 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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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.
|
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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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in competency scores
Time Frame: 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
|
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of skin cancer, sun protection and skin self-examination
Time Frame: 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
Time Frame: 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
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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
Time Frame: 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
|
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Behavioural outcomes (sun protection behaviour and skin self-examination)
Time Frame: 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
|
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Intentions of participants toward carrying out skin cancer risk prevention strategies
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ellie Choi, MBBS, National University Hospital, Singapore
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/00074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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