HRQoL Keratinocyte Carcinomas

NCT04814953 | Enrolling By Invitation DMC

• 1 other identifier: BC-5344
• Study Type: observational
• Target: 2,400
• Locations: 2 countries
• Sites: 2

Brief 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

Basal Cell Carcinoma; Squamous Cell Carcinoma; Actinic Keratoses

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Basal cell carinoma patients

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

Squamous cell carcinoma patients

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

Patients with actinic keratoses

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

Interventions

questionnaires OTHER

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.

Basal cell carinoma patients; Patients with actinic keratoses; Squamous cell carcinoma patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the Department of Dermatology of the University Hospital of Ghent and the Erasmus MC Rotterdam. In addition, patients in other hospitals and dermatology clinics will be asked to participate. Two general practitioners will also include patients with a KC or actinic keratoses.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Erasmus Medical Center: collaborator

Study Sites (2)

Department of Dermatology, Ghent University Hospital

Ghent, 9000, Belgium

Location

MC Rotterdam Department of Dermatology

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Keratosis, Actinic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Precancerous Conditions; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lieve Hoorens, MD, PhD

  Ghent University Hospital, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: March 24, 2021
• Study Start: July 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); NL (1)