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The goal of this European observational study (Frane, Spain, italy, Spain and Greece) is to describe the quality of life related to dermatological toxicities, in adult women patients with Early Breast Cancer (EBC), treated with an ongoing adjuvant endocrine monotherapy initiated for 2 to 3 years ago before inclusion in the study.
In order to answer these objectives, the patient are completing 4 quality of life questionnaires focussed on dermatological issues (DLQI, Skindex-16, Hairdex and ItchyQoL) at the time of the inclusion.
Early Breast Cancer (EBC) diagnosis and history, demographics/clinical characteristics, skin care/sun protection care and skin toxicities since start of the adjuvant endocrine therapy will be collected by the investigator in the eCRF.
Patients will complete the questionnaires at inclusion using a webbased PRO system
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| Measure | Description | Time Frame |
|---|---|---|
| Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire | The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week, including symptoms, feelings, daily activities, leisure, work, school, personal relationships, and treatment. The primary endpoint is the rate of patients with a DLQI score ≥ 6. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired:
| At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life data collected at the time of inclusion using the Skindex-16, Hairdex, and ItchyQoL questionnaires. | The Skindex-16 includes items distributed across three domains symptoms (items 1 to 4), emotions (items 5 to 11) and functioning (items 12 to 16) and are answered on a seven-point Likert scale (varying from 0-never bothered, to 6-always bothered), which represents the frequency with which the skin problem bothered the respondent during the past week. This is a 0-100 scale, higher the score, the more quality of life is impaired. The Hairdex is a valuable tool for evaluating disease-specific QoL in patients with hair disorders. It consists of 48 questions across five sections: symptoms, functioning, emotions, self-confidence, and stigmatization. Each question is self-graded on a scale of 0-4, with a score of 4 indicating the most severe change from a patient's baseline quality of life. The ItchyQoL is a questionnaire used to measure the QoL in patients with chronic pruritus. It is composed of 22 items regarding symptoms, functions, emotions and self-perception, and is currently under |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcomes: History of dermatological toxicities from the beginning of current treatment to the time of inclusion |
| From beginning of current treatment to the time of inclusion |
Inclusion Criteria:
Exclusion Criteria:
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Study population is female patients suffering from EBC and treated with adjuvant endocrine monotherapy for 2 to 3 years, who spontaneously visit a hospital from the EADV European task force, in European countries (including France, Greece, Italy and Spain). They will be invited to participate in the study, during the inclusion period. The study population is the source population meeting eligibility criteria listed hereafter during the inclusion period.
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| Name | Affiliation | Role |
|---|---|---|
| Vincent SIBAUD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut du Cancer de Montpellier - Val d'Aurelle | Montpellier | France | ||||
| Institut Universitaire du Cancer Toulouse - Oncopole |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2025 | Dec 19, 2025 |
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| At inclusion |
| Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017) |
| At inclusion |
| Demographics, and clinical characteristics at the time of inclusion, including the following items |
| At inclusion |
| Subgroups of interest |
Analyses of primary, secondary, and exploratory outcomes may be performed for some or all of these subgroups, subject to pertinence and the number of patients in each subgroup. | At inclusion |
| Toulouse |
| 31100 |
| France |
| Sygros Hospital | Athens | Greece |
| Aristotle University of Thessaloniki | Thessaloniki | Greece |
| Sant'Orsola-Malpighi Hospital University of Bologna | Bologna | Italy |
| Clinica Dermatologica dell'Università di Napoli "Federico II" | Naples | Italy |
| Fondazione Policlinico A. Gemelli | Roma | Italy |
| Hospital Del Mar | Barcelona | Spain |
| Hospital General de Fuerteventura | Las Palmas | Spain |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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