Sexual function, fertility and HRQoL data collected in the questionnaire booklet sent to patients during the quantitative component
| Questionnaire modules | Brief description |
| Sexual function module (FSFI questionnaire) | The FSFI questionnaire is a self-report questionnaire specific to sexual function in women. It was developed by Raymond Rosen37 and a French version has been validated.38 Through its 19 items, it optimally explores six scales (desire, excitement, lubrication, orgasm, satisfaction and pain) of sexual function. Global score ranges from 2 to 36; an overall score <26.5 corresponds to sexual dysfunction. For each scale, a score <3.9 is considered as a deterioration on that scale. |
| Fertility data module | Fertility concerns will be assessed using a study-specific questionnaire developed in conjunction with oncologists, clinicians and surgeons. The items of this module were created for the needs of the study on the basis of clinical routine and diverse French population-based surveys.26 27 39 40 This study does not plan to validate the use of this fertility data module. The purpose of this questionnaire is to assess postcancer fertility in young women who have had BC. Fertility will be quantified by the number of pregnancies that have occurred since the diagnosis of BC. Other data will also be collected, that is: menstrual cycles before and after treatments, parity before and after diagnosis of BC, pregnancy plans at diagnosis and at the end of treatment, information on treatment effects and fertility preservation before treatment, fertility preservation techniques, adoption and current menopausal status. |
| HRQoL module | |
| SF-12 | The SF-12 is a generic questionnaire designed to measure the HRQoL of a general population without specificity regardless of the pathology or even in the absence of pathology. This questionnaire was validated and adapted in French as part of the IQOLA project (International Quality of Life Assessment).41 The questionnaire describes HRQoL in 8 dimensions using 12 items: general health, physical functioning, role physical, role emotional, bodily pain, mental health, vitality and social functioning. A score is calculated for each dimension, it is then possible to calculate an aggregate score of physical HRQoL (Physical Composite Score) as well as an aggregate score for social and mental HRQoL (Mental Composite Score).42 Each of the scores ranges from 0 to 100; 100 representing the best HRQoL for the dimension concerned. |
| EORTC questionnaires | The EORTC questionnaires used in this study are validated in their French-language version and are available on the EORTC website (https://qol.eortc.org/questionnaires/). |
| EORTC QLQ-C30 | The EORTC QLQ-C30 is a self-report questionnaire developed and validated in French by the Quality of Life group (QLG) of the EORTC.43 It assesses 5 functions, 9 symptoms and the overall health of patients through 30 items.44 Standardised scores are calculated such that 0 corresponds to the worst HRQoL and 100 to the best HRQoL for the multi-item dimensions. With regard to symptoms, 0 corresponds to their absence and 100 to their permanent presence. |
| EORTC QLQ-BR23 | The BC-specific EORTC QLQ-BR23 questionnaire is an additional module of the EORTC QLQ-C30 questionnaire. It contains 23 items to assess 4 functional dimensions (body image, sexual functioning, sexual pleasure and future prospects) and 4 symptomatic dimensions (symptoms related to treatment, symptoms in the arm, symptoms in the breast, anxiety related to hair loss) specific to BC and its treatment options. The scoring method of this additional module is the same as for the EORTC QLQ-C30. Published in 1996, it has been translated into >60 languages including French.45 |
| EORTC QLQ-INFO25 | The EORTC QLQ-INFO25 questionnaire was also developed by the EORTC QLG. Through 25 items, this instrument evaluates the level of information that patients received about different areas of their disease, treatment and care and evaluates the qualitative aspects. It generates 4 subscales of disease information (4 items), medical examinations (3 items), treatments (6 items), and other services (4 items) and 8 single items. The 8 single items assess information on other areas and satisfaction with the information provided. The scoring method of the information module is the same as that of the EORTC QLQ-C30.46 |
BC, breast cancer; EORTC, European Organization for Research and Treatment of Cancer; FSFI, Female Sexual Function Index; HRQoL, health-related quality of life; SF-12, Short Form 12.