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Recruiting NCT06761196

Quality of Life After Breast Cancer Surgery

— Observational Breast Cancer Surgery Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire.
Who it may be relevant to
Registry conditions: Breast Cancer Surgery, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessing Quality of Life After Breast Cancer Surgery: a Prospective Cohort Study

Overview

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.

Interventions

  • Other Questionnaire
    The quality of life measured with different scales (BREAST-Q, EORTC QLQ C30 and BR42)

Primary outcome measures

  • Quality of life measured with BREAST-Q [Time frame: From enrollment to the end of 5 years follow-up]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpitaux Civils de Colmar — Colmar

Identifiers

NCT: NCT06761196 · HCC-009 · 2024-A02572-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗