Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Quality of life questionnaire (QLQ); Other: Satisfaction survey; Other: Assessment of patient needs in the field of oncosexology

• Registration Number: NCT06415266
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-16
• Study Start: 2024-08-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2027-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving oncoSexology supportive care on proactive	Quality of life questionnaire (QLQ)	Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.
Patients receiving oncoSexology supportive care on proactive	Satisfaction survey	Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.
Patients receiving oncoSexology supportive care on proactive	Assessment of patient needs in the field of oncosexology	Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.
Patients receiving oncoSexology supportive care on request	Quality of life questionnaire (QLQ)	One-off distribution of a flyer to the patient containing both general information on sexual health and contact telephone numbers and e-mail addresses for oncosexology help
Patients receiving oncoSexology supportive care on request	Satisfaction survey	One-off distribution of a flyer to the patient containing both general information on sexual health and contact telephone numbers and e-mail addresses for oncosexology help

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)
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.
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.
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.

Trial Locations

Locations (9)

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CHU de Nîmes; 🇫🇷 Nîmes, France

Institut Curie; 🇫🇷 Paris, France

IUCT - Oncopole; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Saint-Herblain, Saint Herblain, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, France

Centre Léon Bérard; 🇫🇷 Lyon, France

ICM Val d'Aurelle; 🇫🇷 Montpellier, France