An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients with Early Breast Cancer Treated with Adjuvant Endocrine Therapy - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological Adverse Events)
- Conditions
- Early Breast CancerSkin ConditionQuality of Life
- Registration Number
- NCT06690489
- Lead Sponsor
- Pierre Fabre Medicament
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 156
- Females aged ≥ 18 years at inclusion.
- Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion.
- Still being treated with adjuvant endocrine monotherapy, initiated 2 to 3 years ago before the inclusion in the study.
- Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.
- Patients not able to read, understand and complete Questionnaires in local language.
- with chronic dermatological conditions (treated or not) before initiating the adjuvant endocrine therapy that could interfere with the quality of life.
- Patients with concomitant targeted therapies with adjuvant endocrine therapy such as CDK4/6 inhibitors or trastuzumab, and patients with ongoing treatment with neratinib.
- Patients having relevant or severe comorbidities requiring complex therapeutic treatment.
- Patients having a persistent post-chemotherapy alopecia (at least of grade 1)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 underOngoing 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 toxicityDemographics, 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
Trial Locations
- Locations (4)
Syrgos Hospital
🇬🇷Athenes, Greece
Institut Universitaire du Cancer Toulouse - Oncopole
🇫🇷Toulouse, France
Sant'Orsola-Malpighi Hospital - University of Bologna
🇮🇹Bologne, Italy
Hospital Del Mar
🇪🇸Barcelone, Spain