Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request
NCT ID: NCT06415266
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
264 participants
INTERVENTIONAL
2024-08-09
2028-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Patients receiving oncoSexology supportive care on proactive
Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.
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.
Patients receiving oncoSexology supportive care on request
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
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).
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Metastatic disease
* Patient under guardianship, curatorship or safeguard of justice
18 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Véronique D'HONDT, Dr
Role: PRINCIPAL_INVESTIGATOR
Institut du Cancer de Montpellier (ICM)
Locations
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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
Centre Antoine Lacassagne
Nice, , France
CHU de Nîmes
Nîmes, , France
Institut Curie
Paris, , France
IUCT - Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2023-A02474-41
Identifier Type: OTHER
Identifier Source: secondary_id
PROICM 2023-07 VEN
Identifier Type: -
Identifier Source: org_study_id
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