Actively Recruiting
Development and Evaluation of a Personalized Discharge Letter for Low-risk Skin Cancer Patients After Dermatological Screening
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-22
150
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to support low-risk skin cancer patients after dermatological screening by providing personalized discharge letters. These letters combine evidence-based guidelines with details tailored to each patient's risk profile, aiming to improve patient understanding, reassurance, and self-care compared to the usual general verbal advice. The study is a prospective, randomized controlled trial comparing different methods of aftercare communication. Participants will be randomly assigned to one of three groups: Group A receives standard verbal information only; Group B receives a personalized discharge letter customized to their individual risk, skin type, and consultation findings; and Group C receives the personalized letter plus digital visual support such as annotated images and visual summaries. The personalized letters are generated by an AI agent trained on validated hospital records and reviewed by a physician before being given to patients. During the study, participants' levels of reassurance, knowledge about their personal skin cancer risk, and confidence in performing self-skin checks will be measured immediately after consultation and followed for about one year. Researchers will assess how these different communication approaches affect patient understanding and self-management. The study will continue until June 2029, with data collected through questionnaires and follow-ups related to the aftercare experience.
CONDITIONS
Brief Title
CARES : Customized Aftercare Report for Evaluated Skin Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained prior to screening
- Low-risk skin cancer patients with negative personal history for melanoma
- Fewer than 100 moles (naevi)
- Fewer than 5 clinically atypical moles
- Maximum 1 basal cell carcinoma (BCC) in history
- Maximum 1 squamous cell carcinoma (SCC), at least 5 years ago
- Actinic keratosis (AK) and Bowen's disease treated and controlled with clinical response
- Adults aged between 18 and 80 years at enrollment
You will not qualify if you...
- Presence of skin lesions requiring immediate treatment at consultation
- History of solid organ transplantation
- Known or suspected carriers of germline mutations linked to increased skin cancer risk (e.g. CDKN2A, PTCH1, XP genes)
- Failure to meet inclusion criteria
- Any condition or comorbidity that may interfere with participation or data interpretation (e.g. severe cognitive impairment, language barrier)
- Participation in another interventional clinical trial that may affect study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session at consultation
Participants receive either verbal information only, a personalized discharge letter, or a personalized discharge letter with digital visual support following dermatological screening.
1 baseline visit (in-person)
Duration - Up to 1 year
Participants are followed up for up to 1 year to assess reassurance, knowledge, and confidence in self-skin checks after receiving the intervention.
Periodic assessments during study completion period
Trial Site Locations
Total: 1 location
1
UZLeuven, Department of Dermatology
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
A
Annemiek Leeman, Prof. Dr.
S
Sofie Van Kelst, Bsc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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