NCT06415266

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
27mo left

Started Aug 2024

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Aug 2024Aug 2028

First Submitted

Initial submission to the registry

April 17, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

August 9, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

April 17, 2024

Last Update Submit

August 27, 2025

Conditions

Breast Cancer

Keywords

quality of sexual life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Description of evolution in sexual quality of life

    at inclusion, 6,12,18, and 24 months before inclusion

  • Description of evolution in quality of life - QLQ-C30

    at inclusion, 6,12,18, and 24 months before inclusion

  • Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires.

    at inclusion, 6,12,18, and 24 months before inclusion

  • Search for associations between comorbidities and risk factors

    at inclusion, 6,12,18, and 24 months before inclusion

  • Search for associations between comorbidities and risk factors -questionnaire

    at inclusion, 6,12,18, and 24 months before inclusion

  • +3 more secondary outcomes

Study Arms (2)

Patients receiving oncoSexology supportive care on proactive

EXPERIMENTAL

Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.

Other: Quality of life questionnaire (QLQ)Other: Satisfaction surveyOther: Assessment of patient needs in the field of oncosexology

Patients receiving oncoSexology supportive care on request

OTHER

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

Other: Quality of life questionnaire (QLQ)Other: Satisfaction survey

Interventions

Quality of life questionnaire (QLQ)OTHER

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).

Patients receiving oncoSexology supportive care on proactivePatients receiving oncoSexology supportive care on request
Satisfaction surveyOTHER

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).

Patients receiving oncoSexology supportive care on proactivePatients receiving oncoSexology supportive care on request
Assessment of patient needs in the field of oncosexologyOTHER

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 proactive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Metastatic disease
  • Patient under guardianship, curatorship or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Institut de Cancérologie de l'Ouest

Saint-Herblain, Saint Herblain, 44805, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, 54519, France

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

NOT YET RECRUITING

ICM Val d'Aurelle

Montpellier, 34298, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

NOT YET RECRUITING

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

IUCT - Oncopole

Toulouse, 31100, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29227723BACKGROUND

  • 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.

    PMID: 35028721BACKGROUND

  • 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.

    PMID: 30765487BACKGROUND

  • 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.

    PMID: 19614908BACKGROUND

  • 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.

    PMID: 33233583BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Véronique D'HONDT, Dr

    Institut du Cancer de Montpellier (ICM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore MOUSSION

CONTACT

04 67 61 31 02DRCI-icm105@icm.unicancer.fr

Emmanuelle TEXIER

CONTACT

04 67 61 31 02DRCI-icm105@icm.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2024

First Posted

May 16, 2024

Study Start

August 9, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Locations

FR(9)