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HRQoL Keratinocyte Carcinomas

NCT04814953 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 2400

Last updated 2024-05-09

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Lieve Hoorens, MD, PhD · Ghent University Hospital, Department of Dermatology

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04814953 on ClinicalTrials.gov