HRQoL Keratinocyte Carcinomas

Squamous Cell Carcinoma Clinical Trial

Official title:

HRQoL and Development of Health Utilities in Patients With Keratinocyte Carcinomas

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04814953
• Other study ID #: BC-5344
• Status: Enrolling by invitation
• Start date: July 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

See protocol

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratoses
• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Keratosis
• Keratosis, Actinic
• Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Belgium	Department of Dermatology, Ghent University Hospital	Ghent
Netherlands	MC Rotterdam Department of Dermatology	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Erasmus Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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