HRQoL Keratinocyte Carcinomas

• Conditions: Squamous Cell Carcinoma; Basal Cell Carcinoma; Actinic Keratoses

• Registration Number: NCT04814953
• Lead Sponsor: University Hospital, Ghent

Brief 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).

Detailed Description

See protocol

Study Timeline

• Study First Submitted: 2020-06-16
• Study Start: 2020-07-01
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health utility (by using the 15D questionnaire)	1 year	Utilities as determined by the 15D questionnaire, a generic questionnaire developed to determine a health utility index between 0-1. Lower scores mean less HrQoL.
Health utility (by using a time trade off questionnaire)	1 year	Utilities as determined by the time trade off, this is a technique used to measure the quality of life that a person or group is experiencing. An individual will be presented with a set of directions such as, and the result will be a health utility index between 0-1. Lower scores mean less HrQoL.
Health utility (by using the EQ-5D-5L questionnaire)	1 year	Utilities as determined by the EQ-5D questionnaire, a generic questionnaire developed to determine a health utility index between 0-1. Lower scores mean less HrQoL.

Trial Locations

Locations (2)

Department of Dermatology, Ghent University Hospital; 🇧🇪 Ghent, Belgium

MC Rotterdam Department of Dermatology; 🇳🇱 Rotterdam, Netherlands