Clinical trial NCT06415266: Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request
Official title: Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: quality of sexual life
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm
timeFrame: at 12 months after the inclusion
Secondary outcomes:
measure: Description of evolution in sexual quality of life
timeFrame: at inclusion, 6,12,18, and 24 months before inclusion
measure: Description of evolution in quality of life - QLQ-C30
timeFrame: at inclusion, 6,12,18, and 24 months before inclusion
measure: Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires.
timeFrame: at inclusion, 6,12,18, and 24 months before inclusion
measure: Search for associations between comorbidities and risk factors
timeFrame: at inclusion, 6,12,18, and 24 months before inclusion
measure: Search for associations between comorbidities and risk factors -questionnaire
timeFrame: at inclusion, 6,12,18, and 24 months before inclusion
measure: Assessment of adherence to the programme in the interventional arm
timeFrame: at inclusion
measure: Oncosexology programme satisfaction
timeFrame: at 24 months before inclusion
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
state: Saint Herblain
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
state: Vandoeuvre LES Nancy
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Institut Curie
city: Toulouse
country: France
facility: IUCT - Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut du Cancer de Montpellier (ICM)
name: Véronique D'HONDT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.