Breast Cancer FemaleIDSeinNCT05116449
Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care (IDSein)
An observational study of Breast Cancer Female, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial summary
The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Quality of life questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 310 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Feb 2021to 22 Jan 2026
- Phase
- Observational
- 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
Study population: Women patient with breast cancer
Who may be able to join
- Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled
- Age> 18 years old
- Performance status ECOG <2
- Patient speaking and understanding French and able to complete questionnaires
- Patient affiliated or beneficiary of a social security scheme
- Patient having read the information note and not objecting to the use of the data collected
Who cannot join
- male
- Patient with metastatic breast cancer
- Patient with bilateral breast cancer
- History of cancer of less than 5 years
- Active infection or other serious underlying condition that may prevent the patient from receiving treatment
- History or progressive psychiatric illness
Show all 11Show fewer
- Person deprived of liberty or under guardianship
- Inability to undergo medical monitoring for geographical, social or psychological reasons Indication of emergency amputation
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding or parturient woman
- Patient hospitalized without consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France2 sites, 2 recruiting
- Recruiting
Institut du sein Drôme Ardèche
Guilherand-Granges, 07500
Jean-François Oudet, 0683346567, jf.oudet@ecten.eu
Marie-Hélène Barba, mh.barba@ecten.eu
- Recruiting
Hôpital Privé de l'Estuaire
Le Havre, 76620
Valérie Riquier, Dr, 00332 76 89 95 84, riquier.valerie@wanadoo.fr
About this study
Official title: Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care
The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.
- Conditions
- Breast Cancer Female
- Being tested
- Quality of life questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesBehavioural
Different quality of life questionnaires : FACT-B, EORTC QLQ-C30, QIC, BRIEF COPE, HADS, QSSS-C
| Study group | Role | What they receive |
|---|---|---|
| Patient seeking supportive care | Not described Receives: Behavioral: Quality of life questionnaires | |
| Patient without any supportive care | Not described Receives: Behavioral: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire : FACT-B
Functional Assessment of Cancer Therapy-breast : 27 items about physical well-being, family well-being, emotional and functional well-being. The quotation is between 0 "not at all" and 4 "verry much". The total score is between 0 and 148.
The higher the scores, the higher the QoL and the various well-being.
Measured: 12 months
Quality of life questionnaire : EORTC QLQ-C30
30 items for all patient suffering from cancer. The answer of each question is between 1 "not at all" and 4 "very much"
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start22 Feb 2021
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Jan 2026 (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.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116449
- Sponsor's protocol ID
- 2019-A02397-50
- Acronym
- IDSein
- Status last verified
- Sep 2025
- First submitted
- 4 Nov 2021
- Last updated
- 17 Sep 2025
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care
- ClinicalTrials.gov ID
- NCT05116449
- Acronym / sponsor ID
- IDSein / 2019-A02397-50
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Jan 2026 (estimated)
- First posted
- 11 Nov 2021 (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 study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient seeking supportive care | – | Behavioral: Quality of life questionnaires |
| Patient without any supportive care | – | Behavioral: Quality of life questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women patient with breast cancer
Key inclusion criteria (6 listed)
- Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled
- Age> 18 years old
- Performance status ECOG <2
- Patient speaking and understanding French and able to complete questionnaires
- Patient affiliated or beneficiary of a social security scheme
Key exclusion criteria (11 listed)
- male
- Patient with metastatic breast cancer
- Patient with bilateral breast cancer
- History of cancer of less than 5 years
- Active infection or other serious underlying condition that may prevent the patient from receiving treatment
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 |
|---|---|---|
| Quality of life questionnairesDifferent quality of life questionnaires : FACT-B, EORTC QLQ-C30, QIC, BRIEF COPE, HADS, QSSS-C | Behavioural | Patient seeking supportive care, Patient without any supportive care |
Primary outcome
Quality of life questionnaire : FACT-B
Time frame: 12 months
Functional Assessment of Cancer Therapy-breast : 27 items about physical well-being, family well-being, emotional and functional well-being. The quotation is between 0 "not at all" and 4 "verry much". The total score is between 0 and 148. The higher the scores, the higher the QoL and the various well-being.
Quality of life questionnaire : EORTC QLQ-C30
Time frame: 12 months
30 items for all patient suffering from cancer. The answer of each question is between 1 "not at all" and 4 "very much"
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 17 Sep 2025.
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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.
Marie-Hélène Barba contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 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 6 inclusion and 11 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 17 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 2 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 Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire : FACT-B (time frame: 12 months). The study lists 2 primary outcomes in all. 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 17 Sep 2025.