HRQoL Keratinocyte Carcinomas

Ghent University Hospital (UZ)

Status: Invitation-only

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

Treatments: Other: questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT04814953

BC-5344

Details and patient eligibility

About

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).

Full description

See protocol

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

1. Patient is younger than 18 years old or unable to provide consent.
2. Patient is unable to remember the diagnosis or symptoms of their KC or premalignant lesion upon request by the doctor.
3. Patient was diagnosed with a melanoma or another NMSC.
4. Patient is unable to understand the task and questionnaires.

Trial design

2,400 participants in 3 patient groups

Basal cell carinoma patients

Description:

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)

Treatment:

Other: questionnaires

Squamous cell carcinoma patients

Description:

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)

Treatment:

Other: questionnaires

Patients with actinic keratoses

Description:

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)

Treatment:

Other: questionnaires