Breast Cancer SurgerySOCOM-QoLNCT06761196
Quality of Life After Breast Cancer Surgery
An observational study of Breast Cancer Surgery and Quality of Life, run by Centre Hospitalier de Colmar at 1 site in France.
Trial summary
The goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery. Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Surgery, Quality of Life
- What is being tested?
- Questionnaire
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2025to 1 Sep 2035
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patient aged 18 or over
- Patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk.
- Patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes.
- Patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study.
- Patient with a computer, tablet or smartphone connected to the Internet.
- Patient followed in the center on a regular basis according to standard recommendations.
Who cannot join
- Patient requiring surgical intervention under local anesthesia only.
- Patient requiring surgery for the installation or removal of an chemotherapy implantable port only.
- Patients with a history of cancer other than breast cancer. Patients with a history of cancer more than three years old are eligible if they are treated and considered cured. Patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible.
- Impossibility of being subject to regular monitoring for geographical, social or psychological reasons.
- Patient under protective measure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Civils de Colmar
Colmar, 68024
Massimo Lodi, MD, 0033389124171, massimo.lodi@ch-colmar.fr
Massimo Lodi
About this study
Official title: Assessing Quality of Life After Breast Cancer Surgery: a Prospective Cohort Study
The goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery.
Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.
- Conditions
- Breast Cancer Surgery, Quality of Life
- Being tested
- Questionnaire
- Keywords
- breast cancer, oncoplastic surgery, quality of life, quality of recovery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The quality of life measured with different scales (BREAST-Q, EORTC QLQ C30 and BR42)
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured with BREAST-Q
The BREAST-Q is a rigorously developed patient-reported outcome measure for use in cosmetic and reconstructive breast surgery and clinical practice. The BREAST-Q conceptual framework covers 2 domains: quality of life, and patient satisfaction. There is three independent modules developped for breast cancer (mastectomy, breast-conserving therapy, reconstruction).
A conversion table is used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Measured: From enrollment to the end of 5 years follow-up
Secondary outcomes (4)
Quality of life measured with EORTC QLQ C30
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients.
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: From enrollment to the end of 5 years follow-up
Quality of life measured with EORTC QLQ-BR42
The Breast Cancer Module EORTC QLQ-BR42 is a 42-item instrument designed to measure quality of life in breast cancer patients. It is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. All of the scales and single item measures range in score from 0 to 100. A high score for the Body Image, Sexual Functioning and Breast Satisfaction scales and for the Future Perspective and Sexual Enjoyment single items represents a high level of functioning, whereas a high score for the Systemic ChemoTherapy Side Effects, Endocrine Symptoms, Arm Symptoms, Breast Symptoms, Hand/foot symptoms/neuropathy, Skeletal Scale and Vaginal Symptoms scales and for the Weight Gain single item represents a high level of symptomatology or problems.
Measured: From enrollment to the end of 5 years follow-up
Safety of postoperative period
Concerning safety, the endpoint is the duration of Hospital Free Survival (HFS) . HFS is defined as the time interval (in days) without any hospitalization from discharge until death.
Measured: Form enrollment to the end of 5 years follow-up
Quality of postoperative period
Concerning the quality of the postoperative period, the enpoint is the quality of recovery assessed with the 15-item Quality of Recovery (QoR-15) scale.
The QoR-15 scale is a validated multidimensional questionnaire that measures postoperative quality of recovery. The scale is ranges from 0 to 150. A higher QoR-15 score reflects higher recovery.
Measured: At enrollment aund day 1 and 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start2 Sep 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Colmar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761196
- Sponsor's protocol ID
- HCC-009
- Other IDs
- 2024-A02572-45
- Acronym
- SOCOM-QoL
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 20 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Quality of Life After Breast Cancer Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06761196
- Acronym / sponsor ID
- SOCOM-QoL / HCC-009
- Conditions
- Breast Cancer Surgery, Quality of Life
- Keywords
- breast cancer, oncoplastic surgery, quality of life, quality of recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ColmarUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2035 (estimated)
- First posted
- 7 Jan 2025 (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 goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery.
Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (6 listed)
- Patient aged 18 or over
- Patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk.
- Patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes.
- Patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study.
- Patient with a computer, tablet or smartphone connected to the Internet.
Key exclusion criteria (5 listed)
- Patient requiring surgical intervention under local anesthesia only.
- Patient requiring surgery for the installation or removal of an chemotherapy implantable port only.
- Patients with a history of cancer other than breast cancer. Patients with a history of cancer more than three years old are eligible if they are treated and considered cured. Patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible.
- Impossibility of being subject to regular monitoring for geographical, social or psychological reasons.
- Patient under protective measure
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 |
|---|---|---|
| QuestionnaireThe quality of life measured with different scales (BREAST-Q, EORTC QLQ C30 and BR42) | Other | – |
Primary outcome
Quality of life measured with BREAST-Q
Time frame: From enrollment to the end of 5 years follow-up
The BREAST-Q is a rigorously developed patient-reported outcome measure for use in cosmetic and reconstructive breast surgery and clinical practice. The BREAST-Q conceptual framework covers 2 domains: quality of life, and patient satisfaction. There is three independent modules developped for breast cancer (mastectomy, breast-conserving therapy, reconstruction). A conversion table is used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
4 secondary outcomes
Quality of life measured with EORTC QLQ C30
Time frame: From enrollment to the end of 5 years follow-up
Quality of life measured with EORTC QLQ-BR42
Time frame: From enrollment to the end of 5 years follow-up
Safety of postoperative period
Time frame: Form enrollment to the end of 5 years follow-up
Quality of postoperative period
Time frame: At enrollment aund day 1 and 7 after surgery
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 20 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.
1 site 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 Surgery and Quality of Life, run by Centre Hospitalier de Colmar 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 6 inclusion and 5 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 20 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?
Contact Massimo LODI, MD (0033389124171, massimo.lodi@ch-colmar.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured with BREAST-Q (time frame: From enrollment to the end of 5 years follow-up). 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 20 Oct 2026.