NCT04814953

HRQoL Keratinocyte Carcinomas

HRQoL and Development of Health Utilities in Patients With Keratinocyte Carcinomas

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 2,400 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Basal Cell Carcinoma
• Squamous Cell Carcinoma
• Actinic Keratoses

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-03-24
• Last updated: 2024-05-09

Locations

2 sites across 2 countries: Belgium, Netherlands