Breast Cancer
Conditions
Keywords
quality of sexual life
Brief summary
The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients.
Detailed description
Breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. Given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. Sexual health is a crucial component of well-being and overall quality of life. The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. For that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years.
Interventions
Quality of life questionnaire : EORTC QLQ-C30, EORTC QLQ-Breast cancer module (BR) 23, EORTC SHQ-C22 et HADS at inclusion, visit 1 (6 months +/-1 month before the inclusion), visit 2 (12 months +/-1 month before the inclusion), visit 3 (18 months +/-1 month before the inclusion) and visit 4 (24 months +/-1 month before the inclusion).
OTHERSatisfaction survey
The satisfaction score will be collected using a visual analog scale from 0 to 10 and the satisfaction questionnaire will also be completed at visit 4 (24 months +/- 1 month before the inclusion).
OTHERAssessment of patient needs in the field of oncosexology
Assessment of patient needs in the field of oncosexology during a face-to-face or virtual interview at inclusion and every 6 months for 2 years. If a need is identified, an oncosexology consultation will be organised. Following this, a personalised care plan may be proposed.
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman or man at least 18 years old * Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor * Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously * Patient with sufficient command of the French language to be able to answer the questionnaires * Patient having given informed, written and express consent. * Affiliation to the French Social Security System * Willingness and ability to comply with scheduled visits, treatment plan and other study procedures
Exclusion criteria
* Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments) * Metastatic disease * Patient under guardianship, curatorship or safeguard of justice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm | at 12 months after the inclusion | EORTC Sexual Health Questionnaire (SHQ)-C22 specific questionnaire sexual satisfaction scale score. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of evolution in quality of life - QLQ-C30 | at inclusion, 6,12,18, and 24 months before inclusion | Scores obtained on the scales of the EORTC QLQ-C30. Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires. | at inclusion, 6,12,18, and 24 months before inclusion | Scores obtained on the scales of the QLQ-BR23 This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms. |
| Search for associations between comorbidities and risk factors | at inclusion, 6,12,18, and 24 months before inclusion | Coefficients obtained with a model adapted for longitudinal quality of life data scores as a function of covariates potentially associated with sexual and global quality of life. |
| Description of evolution in sexual quality of life | at inclusion, 6,12,18, and 24 months before inclusion | Scores obtained on the EORTC SHQ-C22 questionnaire scales. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level. |
| Assessment of adherence to the programme in the interventional arm | at inclusion | Percentage of adherence in the interventional arm |
| Oncosexology programme satisfaction | at 24 months before inclusion | Satisfaction score measured on a visual analogue scale ranging from 1 to 10 (10 indicating high satisfaction) |
| Search for associations between comorbidities and risk factors -questionnaire | at inclusion, 6,12,18, and 24 months before inclusion | Anxiety and depression (psychological distress variables) will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. |
Countries
France
Contacts
Primary ContactAurore MOUSSION
Backup ContactEmmanuelle TEXIER
Outcome results
None listed