HRQoL Keratinocyte Carcinomas

• Conditions: Squamous Cell Carcinoma; Basal Cell Carcinoma; Actinic Keratoses
• Interventions: Other: questionnaires

• 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

Arm && Interventions

Group	Intervention	Description
Basal cell carinoma patients	questionnaires	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)
Squamous cell carcinoma patients	questionnaires	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)
Patients with actinic keratoses	questionnaires	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)

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