HRQoL Keratinocyte Carcinomas

Study Overview
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Brief Summary
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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
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See protocol

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

Conditions
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Basal Cell Carcinoma, Squamous Cell Carcinoma, Actinic Keratoses

Intervention / Treatment
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* Other: questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 1. Patients with one or more premalignant lesion or KC diagnosed by a dermatologist or by histopathology untill 10 years previous to inclusion. Exclusion criteria Patient is younger than 18 years old or unable to provide consent. Patient is unable to remember the diagnosis or symptoms of their KC or premalignant lesion upon request by the doctor. Patient was diagnosed with a melanoma or another NMSC. Patient is unable to understand the task and questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basal cell carinoma patients<br>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) | Other: questionnaires<br>* 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.<br>|
| Squamous cell carcinoma patients<br>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) | Other: questionnaires<br>* 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.<br>|
| Patients with actinic keratoses<br>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) | Other: questionnaires<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health utility (by using a time trade off questionnaire) | 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. | 1 year | 
| Health utility (by using the 15D questionnaire) | 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. | 1 year | 
| Health utility (by using the EQ-5D-5L questionnaire) | 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. | 1 year |