Breast Cancer FemaleSISTERNCT06583460
Systematic Intervention to Improve Sexual Dysfunction
A study testing Early and systematic oncosexological supporting care in people with Breast Cancer Female and Localized Cancer, run by Center Eugene Marquis at 1 site in France.
Trial summary
The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Localized Cancer
- What is being tested?
- Early and systematic oncosexological supporting care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2024to 9 Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 18 years (menopausal or not),
- Localized breast cancer with or without lymph node involvement,
- Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.),
- Patient affiliated or benefiting from the social security system,
- Patient informed and informed consent signed.
Who cannot join
- History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years,
- Pregnant or breast-feeding women,
- Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards,
- Patients unable to comply with the study schedule for social, medical or psychological reasons.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042
About this study
Official title: Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients
The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.
Read the detailed description
The aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand.
All included patients are evaluated at Baseline and M18 following initiation of antineoplastic treatments associated with surgery. Patients who accepted additional oncosexological care were also assessed at M4, M8 and M12. The content of support care is detailed in section "arms and interventions".
Oncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.
- Conditions
- Breast Cancer Female, Localized Cancer
- Being tested
- Early and systematic oncosexological supporting care
- Keywords
- Sexual dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early and systematic oncosexological supporting careOther
Each patient included in the study will be cared by an anthropologist and a sexologist.
This therapeutic support care will be based on :
- 2 qualitative semi-directive interviews (Baseline and M18),
- 2 individual consultations with questionnaires (Baseline and M18).
The qualitative semi-structured interviews will be conducted with the anthropologist, and the individual consultations with the sexologist.
At the end of the first oncosexology consultation, patients will be given the opportunity to decide whether or not to accept further systematic oncosexology support care, which will be based on :
- 3 individual and/or couple consultations,
- 3 group workshops.
Patients are under no obligation to accept this additional oncosexology support care.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer treatment with oncosexology supporting care | Other | Patient initially treated by surgery combined with any therapy (chemotherapy, radiotherapy, hormonal therapy etc.) and benefiting oncosexological care. Receives: Other: Early and systematic oncosexological supporting care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual satisfaction
Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).
Measured: Measured at baseline and at 18 months following initiation of treatment and surgical.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start9 Dec 2024
- Primary completion9 Jun 2028 (estimated)
- Study completion9 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Category 2 clinical trial, monocentric, prospective, comparative, controlled but not randomized
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Lefeuvre-Plesse, MD, Principal investigator, Centre de Lutte Contre Le cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583460
- Sponsor's protocol ID
- 2023-4-72-002
- Other IDs
- 2023-A02035-40
- Acronym
- SISTER
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06583460
- Acronym / sponsor ID
- SISTER / 2023-4-72-002
- Conditions
- Breast Cancer Female, Localized Cancer
- Keywords
- Sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 9 Jun 2028 (estimated)
- Study completion
- 9 Jun 2028 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.
Detailed description
The aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand.
All included patients are evaluated at Baseline and M18 following initiation of antineoplastic treatments associated with surgery. Patients who accepted additional oncosexological care were also assessed at M4, M8 and M12. The content of support care is detailed in section "arms and interventions".
Oncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Category 2 clinical trial, monocentric, prospective, comparative, controlled but not randomized
| Arm | Type | Receives |
|---|---|---|
| Breast cancer treatment with oncosexology supporting care | Other | Other: Early and systematic oncosexological supporting carePatient initially treated by surgery combined with any therapy (chemotherapy, radiotherapy, hormonal therapy etc.) and benefiting oncosexological care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women ≥ 18 years (menopausal or not),
- Localized breast cancer with or without lymph node involvement,
- Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.),
- Patient affiliated or benefiting from the social security system,
- Patient informed and informed consent signed.
Key exclusion criteria (4 listed)
- History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years,
- Pregnant or breast-feeding women,
- Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards,
- Patients unable to comply with the study schedule for social, medical or psychological reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early and systematic oncosexological supporting careEach patient included in the study will be cared by an anthropologist and a sexologist. This therapeutic support care will be based on : * 2 qualitative semi-directive interviews (Baseline and M18), * 2 individual consultations with questionnaires (Baseline and M18). The qualitative semi-structured interviews will be conducted with the anthropologist, and the individual consultations with the sexologist. At the end of the first oncosexology consultation, patients will be given the opportunity to decide whether or not to accept further systematic oncosexology support care, which will be based on : * 3 individual and/or couple consultations, * 3 group workshops. Patients are under no obligation to accept this additional oncosexology support care. | Other | Breast cancer treatment with oncosexology supporting care |
Primary outcome
Sexual satisfaction
Time frame: Measured at baseline and at 18 months following initiation of treatment and surgical.
Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Lefeuvre-Plesse, MD principal investigator
Centre de Lutte Contre Le cancer Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early and systematic oncosexological supporting care in people with Breast Cancer Female and Localized Cancer, run by Center Eugene Marquis at 1 site 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual satisfaction (time frame: Measured at baseline and at 18 months following initiation of treatment and surgical.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.