Study design and subject recruitment
This unicentric prospective study (CUPIDON 2) was conducted in the Institut du Cancer de Montpellier (ICM). The protocol was approved by the French Ethics Committee and the internal review board of the institution. Patients received an information letter and all provided written consent before the enrolment. The primary objective was to evaluate the sexual QoL of women younger than 51 years old, with HR+ BC who had received their endocrine therapy for at least 24 months, using the EORTC SHQ-22 questionnaire. The secondary objectives were (1) to evaluate the global QoL at the same time-point using the EORTC QLQ-C30  and QLQ-BR23  questionnaires; (2) to evaluate the information received by patients about sexual issues; (3) to evaluate the need for specific management of sexual troubles and (4) to describe supportive measures or therapeutic interventions used by women on their own initiative using the specific Cupidon questionnaire, proposed for the study. Eligible women were between 18 and 51 years old, sexually active, displaying HR+ early BC, having completed surgery as well as chemotherapy and/or radiotherapy when indicated. They all had received their endocrine therapy for at least 24 months.
Data and measures
General health and socio-demographic information, including employment status, physical activity and partner status were self-reported by participants. Age, weight, size, menopausal status, pathology report, type of treatment (type of surgery, radiotherapy, chemotherapy) as well as co-morbidities were collected from the medical records.
Patients were invited to complete the three EORTC HRQLQ only once.
The general EORTC QLQ-C30 questionnaire dedicated to all cancer patients includes 30 items assessing the global health status with 5 functional scores (physical, role, cognitive, social and emotional) and 9 symptom scores (nausea and vomiting, pain, fatigue, dyspnea, sleeping disturbances, appetite loss, constipation, diarrhea and financial difficulties).
The specific EORTC QLQ-BR23 module dedicated to breast cancer patients includes 23 items allowing to assess 4 functional scores (body image, sexual functioning, sexual enjoyment, future perspective) and 4 symptom scores (systemic side effects, arm symptoms, breast symptoms, being upset by the hair loss).
The EORTC SHQ-22 is a multidimensional QoL instrument used to measure sexual health in patients with cancer (men or women). This new tool covers both sexual functioning and psychosexual components. It includes 8 items on sexual satisfaction, 3 items on sexual pain and 11 single items, in an integrative approach, leading to 7 functional scales and 4 symptom scales.
In these questionnaires, higher scores in the functioning scales indicate better functional level whereas higher scores in the symptom scales indicate rather severity of problems. A user agreement for the use of the EORTC SHQ-22 was signed.
In addition, a home-made questionnaire containing 11 questions was proposed to patients in order to explore (1) the information regarding sexuality received during treatment, (2) the supportive measures or therapeutic interventions used by patients to overcome sexual dysfunction, (3) the need and acceptability for specific management of sexual dysfunction. This specific Cupidon questionnaire is reproduced in extenso in the supplemental data.
In this descriptive study, the sample size was based on the recruitment capacity of our institution, which represented a potential of around 50 patients meeting the inclusion criteria of the study for the planned duration. Considering an 80% acceptance rate (20% of refusal), a total of 40 patients were expected to participate. The inclusion of at least 40 patients permits to estimate (for descriptive purposes) the mean scores of the dimensions of the EORTC SHQ-22 (ranged from 0 to 100) and its 95% confidence intervals (95% CI) with a width of 15, and hypothesizing a standard deviation of 24 .
Scorings of the three EORTC HRQLQ were calculated according to the EORTC Scoring Manuals and results were presented as means and standard deviations (SD). Categorical variables were described using frequencies and percentages.
Statistical analysis was performed using the Stata v16 software (College Station, TX, 2019).