Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07330323

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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)

Long-term Monitoring

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

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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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