Quality of Life After Breast Cancer Surgery (SOCOM-QoL)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Breast Cancer Surgery
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Massimo Lodi, MD; Phone Number: 0033389124171; Email: massimo.lodi@ch-colmar.fr
• Study Contact Backup: Name: Magali EYRIEY; Phone Number: 0033389124810; Email: magali.eyriey@ch-colmar.fr

Study Locations

• France
  • Colmar, France, 68024
    • Recruiting
    • Hôpitaux Civils de Colmar
    • Contact: Massimo Lodi, MD; Phone Number: 0033389124171; Email: massimo.lodi@ch-colmar.fr
    • Principal Investigator: Massimo Lodi
    • Sub-Investigator: Delphine Weitbruch
    • Sub-Investigator: Sylvia Mazellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of 5 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At enrollment aund day 1 and 7 after surgery
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.	From enrollment to the end of 5 years follow-up

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Colmar

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2035

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): January 7, 2025

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; quality of recovery; oncoplastic surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: HCC-009; 2024-A02572-45 (Other Identifier: ID-RCB - ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No