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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
264
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).
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).
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.
Institut de Cancérologie de l'Ouest
Saint-Herblain, Saint Herblain, France
RECRUITINGInstitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, France
RECRUITINGCentre Léon Bérard
Lyon, France
Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm
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.
Time frame: at 12 months after the inclusion
Description of evolution in sexual quality of life
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.
Time frame: at inclusion, 6,12,18, and 24 months before inclusion
Description of evolution in quality of life - QLQ-C30
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.
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ICM Val d'Aurelle
Montpellier, France
RECRUITINGCentre Antoine Lacassagne
Nice, France
NOT_YET_RECRUITINGCHU de Nîmes
Nîmes, France
RECRUITINGInstitut Curie
Paris, France
RECRUITINGIUCT - Oncopole
Toulouse, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France
RECRUITINGTime frame: at inclusion, 6,12,18, and 24 months before inclusion
Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires.
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.
Time frame: at inclusion, 6,12,18, and 24 months before inclusion
Search for associations between comorbidities and risk factors
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.
Time frame: at inclusion, 6,12,18, and 24 months before inclusion
Search for associations between comorbidities and risk factors -questionnaire
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.
Time frame: at inclusion, 6,12,18, and 24 months before inclusion
Assessment of adherence to the programme in the interventional arm
Percentage of adherence in the interventional arm
Time frame: at inclusion
Oncosexology programme satisfaction
Satisfaction score measured on a visual analogue scale ranging from 1 to 10 (10 indicating high satisfaction)
Time frame: at 24 months before inclusion
Oncosexology programme satisfaction
Scores obtained of the Satisfaction questionnaire by arm. All the scale ranging from 1 to 5 (5 indicating high satisfaction).
Time frame: at 24 months before inclusion