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

Breast Cancer Clinical Trial

— VENUS  

Official title:

Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415266
• Other study ID #: PROICM 2023-07 VEN
• Secondary ID: 2023-A02474-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2028

Study information

• Verified date: May 2024
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Aurore MOUSSION
• Phone: 04 67 61 31 02
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: May 2028
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Quality of life questionnaire (QLQ)
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).
• Satisfaction 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).
• Assessment 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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon
France	ICM Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	CHU de Nîmes	Nîmes
France	Institut Curie	Paris
France	Institut de Cancérologie de l'Ouest	Saint-Herblain	Saint Herblain
France	IUCT - Oncopole	Toulouse
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy	Vandoeuvre LES Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (5)

Bobrie A, Jarlier M, Moussion A, Jacot W, D'Hondt V. Sexual quality of life assessment in young women with breast cancer during adjuvant endocrine therapy and patient-reported supportive measures. Support Care Cancer. 2022 Apr;30(4):3633-3641. doi: 10.1007/s00520-022-06810-3. Epub 2022 Jan 14. — View Citation

Carter J, Lacchetti C, Andersen BL, Barton DL, Bolte S, Damast S, Diefenbach MA, DuHamel K, Florendo J, Ganz PA, Goldfarb S, Hallmeyer S, Kushner DM, Rowland JH. Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline. J Clin Oncol. 2018 Feb 10;36(5):492-511. doi: 10.1200/JCO.2017.75.8995. Epub 2017 Dec 11. — View Citation

Del Pup L, Villa P, Amar ID, Bottoni C, Scambia G. Approach to sexual dysfunction in women with cancer. Int J Gynecol Cancer. 2019 Mar;29(3):630-634. doi: 10.1136/ijgc-2018-000096. Epub 2019 Feb 13. — View Citation

Dizon DS. Quality of life after breast cancer: survivorship and sexuality. Breast J. 2009 Sep-Oct;15(5):500-4. doi: 10.1111/j.1524-4741.2009.00766.x. Epub 2009 Jul 14. — View Citation

Seguin L, Touzani R, Bouhnik AD, Charif AB, Marino P, Bendiane MK, Goncalves A, Gravis G, Mancini J. Deterioration of Sexual Health in Cancer Survivors Five Years after Diagnosis: Data from the French National Prospective VICAN Survey. Cancers (Basel). 2020 Nov 20;12(11):3453. doi: 10.3390/cancers12113453. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 12 months after the inclusion
Secondary	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.	at inclusion, 6,12,18, and 24 months before inclusion
Secondary	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.	at inclusion, 6,12,18, and 24 months before inclusion
Secondary	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.	at inclusion, 6,12,18, and 24 months before inclusion
Secondary	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.	at inclusion, 6,12,18, and 24 months before inclusion
Secondary	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.	at inclusion, 6,12,18, and 24 months before inclusion
Secondary	Assessment of adherence to the programme in the interventional arm	Percentage of adherence in the interventional arm	at inclusion
Secondary	Oncosexology programme satisfaction	Satisfaction score measured on a visual analogue scale ranging from 1 to 10 (10 indicating high satisfaction)	at 24 months before inclusion