Early Breast Cancer, Quality of Life, Skin Condition
Conditions
Keywords
Early breast cancer, Adjuvant endocrine therapy, Quality of life, Patient Reported Outcomes, skin toxicities
Brief summary
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.
Detailed description
Patients will complete the questionnaires at inclusion using a webbased PRO system
Interventions
None listed
Sponsors
Pierre Fabre Medicament
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Females aged ≥ 18 years at inclusion. 2. Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion. 3. Still being treated with adjuvant endocrine monotherapy, initiated 2 years (up to 1 year and 9 months) to 3 years (up to 3 years and 6 months) before the inclusion in the study. 4. Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.
Exclusion criteria
1. Patients not able to read, understand and complete Questionnaires in local language. 2. with chronic dermatological conditions (treated or not) before initiating the adjuvant endocrine therapy that could interfere with the quality of life. 3. Patients with concomitant targeted therapies with adjuvant endocrine therapy such as CDK4/6 inhibitors or trastuzumab, and patients with ongoing treatment with neratinib. 4. Patients having relevant or severe comorbidities requiring complex therapeutic treatment. 5. Patients having a persistent post-chemotherapy alopecia (at least of grade 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire | At inclusion | 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: * 0 - 1 corresponds to no effect at all on patient's life, * 2 - 5 corresponds to small effect on patient's life, * 6 - 10 corresponds to moderate effect on patient's life, * 11 - 20 corresponds to very large effect on patient's life, * 21 - 30 corresponds to extremely large effect on patient's life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life data collected at the time of inclusion using the Skindex-16, Hairdex, and ItchyQoL questionnaires. | At inclusion | 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 |
| Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017) | At inclusion | 1. Type of toxicity 2. Surface area involved (except for nails and oral dryness) 3. Start date 4. Clinical grading of the toxicity |
| Demographics, and clinical characteristics at the time of inclusion, including the following items | At inclusion | 1. Age, gender, weight, height 2. Menopausal status 3. Date of cancer diagnosis 4. Primary tumor location 5. T stage 6. Prior therapies for breast cancer (type, agent name, start date, stop date) 7. Endocrine therapy (agent name, start date) for breast cancer 8. Current dermatological care and sun-protective behaviors |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1. Type of dermatological toxicity 2. Surface area (except for nails and oral dryness) 3. Start date and end date 4. Grade of the toxicity, if available 5. Change in hormonal treatment (adaptation, interruption), if applicable |
| Subgroups of interest | At inclusion | * Age repartition by class (\< 35 years old, 35-50, 50-65, \> 65 years old) * Menopause status * Therapeutical choice before the 2/3 years of adjuvant endocrine therapy * Radiotherapy (yes / no) * Chemotherapy (yes / no), if yes, the information whether taxane was received or not will be collected * Adjuvant (yes/no) * Neoadjuvant (yes/no) * Target therapy (yes / no) * Type of adjuvant endocrine therapy 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. |
Countries
France, Greece, Italy, Spain
Outcome results
None listed