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
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