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AzTrials

Breast CancerVENUSNCT06415266

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

A study testing Quality of life questionnaire (QLQ), Satisfaction survey and Assessment of patient needs in the field of oncosexology in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Quality of life questionnaire (QLQ), Satisfaction survey and Assessment of patient needs in the field of oncosexology
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
9 sitesFrance
Study dates
9 Aug 2024to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aurore MOUSSION contact

04 67 61 31 02 ext. +33

DRCI-icm105@icm.unicancer.fr

Emmanuelle TEXIER contact

04 67 61 31 02 ext. +33

DRCI-icm105@icm.unicancer.fr

9 sites in 1 country

France9 sites, 9 recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Philippe TOUSSAINT, Dr, 04 78 78 28 40 ext. +33, philippe.toussaint@lyon.unicancer.fr

    Not yet recruiting

  • ICM Val d'Aurelle

    Montpellier, 34298

    Véronique D'HONDT, Dr, 04 67 61 25 07 ext. +33, Veronique.Dhondt@icm.unicancer.fr

    Angélique BOBRIE, Dr, 04 67 61 85 76 ext. +33, Angelique.Bobrie@icm.unicancer.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Anne CREISSON, Dr, 04 92 03 16 43 ext. +33, anne.creisson@nice.unicancer.fr

    Not yet recruiting

  • CHU de Nîmes

    Nîmes, 30029

    Frédéric FITENI, Dr, 04 66 68 33 01 ext. +33, frederic.fiteni@chu-nimes.fr

    Recruiting

  • Institut Curie

    Paris, 75005

    Silène DELORME, silene.delorme@curie.fr

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Saint Herblain, 44805

    Aliette DEZELLUS, Dr, 02 40 67 99 00 ext. +33, aliette.dezellus@ico.unicancer.fr

    Recruiting

  • IUCT - Oncopole

    Toulouse, 31100

    Eva JOUVE, Dr, 05 31 15 60 16 ext. +33, jouve.eva@iuct-oncopole.fr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, 54519

    Claire CHARRA-BRUNAUD, Dr, 03 83 59 86 10 ext. +33, c.brunaud@nancy.unicancer.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Marion AUPOMEROL, Dr, Marion.AUPOMEROL@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Quality of life questionnaire (QLQ), Satisfaction survey, Assessment of patient needs in the field of oncosexology
Keywords
quality of sexual life
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • 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).

  • 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.

Study groups in NCT06415266
Study groupRoleWhat they receive
Patients receiving oncoSexology supportive care on proactiveExperimentalRepeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.
Receives: Other: Quality of life questionnaire (QLQ); Other: Satisfaction survey; Other: Assessment of patient needs in the field of oncosexology
Patients receiving oncoSexology supportive care on requestOtherOne-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
Receives: Other: Quality of life questionnaire (QLQ); Other: Satisfaction survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 12 months after the inclusion

Secondary outcomes (8)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. Assessment of adherence to the programme in the interventional arm

    Percentage of adherence in the interventional arm

    Measured: at inclusion

  7. Oncosexology programme satisfaction

    Satisfaction score measured on a visual analogue scale ranging from 1 to 10 (10 indicating high satisfaction)

    Measured: at 24 months before inclusion

  8. Oncosexology programme satisfaction

    Scores obtained of the Satisfaction questionnaire by arm. All the scale ranging from 1 to 5 (5 indicating high satisfaction).

    Measured: at 24 months before inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start9 Aug 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06415266
Sponsor's protocol ID
PROICM 2023-07 VEN
Other IDs
2023-A02474-41
Acronym
VENUS
Status last verified
Aug 2025
First submitted
17 Apr 2024
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Publications

  • 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.

    PubMed 29227723

  • 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.

    PubMed 35028721

  • 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.

    PubMed 30765487

  • 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.

    PubMed 19614908

  • 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.

    PubMed 33233583

Questions about this trial

What is this clinical trial studying?

A study testing Quality of life questionnaire (QLQ), Satisfaction survey and Assessment of patient needs in the field of oncosexology in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurore MOUSSION (04 67 61 31 02 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm (time frame: at 12 months after the inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06415266, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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