Quality of Life After Breast Cancer Surgery

Recruiting

• Conditions: Breast Cancer Surgery; Quality of Life

• Registration Number: NCT06761196
• Lead Sponsor: Centre Hospitalier de Colmar

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-30
• Study First Posted: 2025-01-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Study Start: 2025-06-01
• Primary Completion: 2030-06-01
• Study Completion: 2035-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measured with BREAST-Q	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life measured with EORTC QLQ C30	From enrollment to the end of 5 years follow-up	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.
Quality of life measured with EORTC QLQ-BR42	From enrollment to the end of 5 years follow-up	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.
Safety of postoperative period	Form enrollment to the end of 5 years follow-up	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.
Quality of postoperative period	At enrollment aund day 1 and 7 after surgery	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.

Trial Locations

Locations (1)

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France