Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
2400 participants
OBSERVATIONAL
2020-07-01
2025-12-31
Brief Summary
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Objective: To document the exact HRQoL in patients with in KC using the generic EQ-5D-5L questionnaire, as well as the TTO, 15D and the BaSQoL questionnaire, and to develop health utilities based on these tools.
Study design: Longitudinal observational study (at time 0 and time 0 +12 months).
Study population: Patients aged ≥18 years consulting a dermatologist or their GP for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Basal cell carinoma patients
Patients with basal cell carcinoma in history (up to 10 years before inclusion) with or without squamous cell carcinoma or actinic keratosis but no other skin cancers (melanoma or non-melanoma skin cancer)
questionnaires
EQ-5D-5L questionnaire questioning their overall health on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In addition patients will have to fill in the generic 15D questioning 15 specific dimensions on 5 levels as well as the BaSQoL, which is a disease specific questionnaire for patients with KC. The Time-trade off task is the final question.
Squamous cell carcinoma patients
Patients with squamous cell carcinoma in history (up to 10 years before inclusion) with or without basal cell carcinoma or actinic keratosis but no other skin cancers (melanoma or non-melanoma skin cancer)
questionnaires
EQ-5D-5L questionnaire questioning their overall health on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In addition patients will have to fill in the generic 15D questioning 15 specific dimensions on 5 levels as well as the BaSQoL, which is a disease specific questionnaire for patients with KC. The Time-trade off task is the final question.
Patients with actinic keratoses
Patients with actinic keratosis in history (up to 10 years before inclusion) with or without basal cell carcinoma or squamous cell carcinomas but no other skin cancers (melanoma or non-melanoma skin cancer)
questionnaires
EQ-5D-5L questionnaire questioning their overall health on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In addition patients will have to fill in the generic 15D questioning 15 specific dimensions on 5 levels as well as the BaSQoL, which is a disease specific questionnaire for patients with KC. The Time-trade off task is the final question.
Interventions
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questionnaires
EQ-5D-5L questionnaire questioning their overall health on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In addition patients will have to fill in the generic 15D questioning 15 specific dimensions on 5 levels as well as the BaSQoL, which is a disease specific questionnaire for patients with KC. The Time-trade off task is the final question.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patient is unable to remember the diagnosis or symptoms of their KC or premalignant lesion upon request by the doctor.
3. Patient was diagnosed with a melanoma or another NMSC.
4. Patient is unable to understand the task and questionnaires.
18 Years
100 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Lieve Hoorens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ghent University Hospital, Department of Dermatology
Locations
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Department of Dermatology, Ghent University Hospital
Ghent, , Belgium
MC Rotterdam Department of Dermatology
Rotterdam, , Netherlands
Countries
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Other Identifiers
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BC-5344
Identifier Type: -
Identifier Source: org_study_id
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