CARES : Customized Aftercare Report for Evaluated Skin Cancer Patients
CARES
Development and Evaluation of a Personalized Discharge Letter for Low-risk Skin Cancer Patients After Dermatological Screening.
1 other identifier
interventional
150
1 country
1
Brief Summary
Current clinical practices often provide general verbal advice to low-risk patients, which may not sufficiently address individual concerns or offer actionable steps. Generic information on the internet can be overwhelming or unreliable, leading to confusion and unnecessary follow-up visits. This project introduces a tailored approach by combining evidence-based guidelines with personalized details about the patient's risk profile. The discharge letter bridges the gap between clinical expertise and patient understanding, offering clear, specific, and actionable advice that has been shown to improve health behaviors and outcomes in other contexts . The personalized discharge letters are generated using an AI agent trained on validated letters from the hospital's electronic health record system (KWS). Each letter is reviewed and approved by a physician before being provided to the patient, ensuring both accuracy and clinical relevance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
January 9, 2026
December 1, 2025
3 years
December 17, 2025
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Level of Reassurance Immediately Post-Consultation
Measured via a questionnaire. Hypothesis: Patients in the IntelliStudio group will report the highest levels of reassurance.
Through study completion, an average of 1 year
Knowledge of Personal Skin Cancer Risk
Assessed through a pre- and post-intervention knowledge questionnaire. Hypothesis: Personalized information (Groups B and C) improves risk awareness compared to standard care.
Through study completion, an average of 1 year
Confidence in Performing Self-Skin Checks
Measured via self-reported confidence and frequency of self-checks. Hypothesis: Groups B and C will report higher confidence than Group A.
Through study completion, an average of 1 year
Study Arms (3)
Group A: Standard of Care
ACTIVE COMPARATORVerbal information only.
Group B: Personalized Discharge Letter
EXPERIMENTALTailored written information based on individual risk profile, skin type and consultation findings.
Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio)
EXPERIMENTALTailored written information plus digital visual support (e.g. annotated images, visual summaries).
Interventions
Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.
Personalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
Eligibility Criteria
You may qualify if:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Low-risk skin cancer patients:
- Negative personal history for melanoma
- Less than 100 naevi
- Less than 5 clinically atypical naevi
- Maximum 1 BCC in history
- Maximum 1 SCC, and at least 5 years ago
- AK: treated and controlled with clinical response
- M Bowen: treated and controlled with clinical response
- Adult subjects (between 18 years of age and 80 years) at time of enrolment
You may not qualify if:
- Presence of dermatological lesions requiring immediate treatment at the time of consultation.
- History of solid organ transplantation (Organ Transplant Recipient, OTR).
- Known carriers or suspected carriers (based on family history) of germline mutations associated with increased skin cancer risk (e.g. CDKN2A, PTCH1, XP genes).
- Any condition or comorbidity that, in the opinion of the investigator, may interfere with study participation or data interpretation (e.g. severe cognitive impairment, language barrier).
- Participation in another interventional clinical trial that may interfere with the outcomes of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZLeuven, Department of Dermatology
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2025
First Posted
January 9, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
January 9, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share