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NCT04814953

HRQoL Keratinocyte Carcinomas

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

Summary

Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available. 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).

Official title: HRQoL and Development of Health Utilities in Patients With Keratinocyte Carcinomas

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

2400

Start Date

2020-07-01

Completion Date

2025-12-31

Last Updated

2024-05-09

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (2)

Department of Dermatology, Ghent University Hospital

Ghent, Belgium

MC Rotterdam Department of Dermatology

Rotterdam, Netherlands