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Recruiting NCT05116449

Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care (IDSein)

Observational Breast Cancer Female

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: Quality of life questionnaires.
Who it may be relevant to
Registry conditions: Breast Cancer Female. Basic parameters: from 18 years · Female.
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 →
Official title

Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care

Overview

The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.

Interventions

  • Behavioral Quality of life questionnaires
    Different quality of life questionnaires : FACT-B, EORTC QLQ-C30, QIC, BRIEF COPE, HADS, QSSS-C

Primary outcome measures

  • Quality of life questionnaire : FACT-B [Time frame: 12 months]
  • Quality of life questionnaire : EORTC QLQ-C30 [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled
  • Age> 18 years old
  • Performance status ECOG <2
  • Patient speaking and understanding French and able to complete questionnaires
  • Patient affiliated or beneficiary of a social security scheme
  • Patient having read the information note and not objecting to the use of the data collected

Exclusion criteria

  • male
  • Patient with metastatic breast cancer
  • Patient with bilateral breast cancer
  • History of cancer of less than 5 years
  • Active infection or other serious underlying condition that may prevent the patient from receiving treatment
  • History or progressive psychiatric illness
  • Person deprived of liberty or under guardianship
  • Inability to undergo medical monitoring for geographical, social or psychological reasons Indication of emergency amputation
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, breastfeeding or parturient woman
  • Patient hospitalized without consent

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
Case-control

Study locations

France · 2 centers
  • Institut du sein Drôme Ardèche — Guilherand-Granges
  • Hôpital Privé de l'Estuaire — Le Havre

Identifiers

NCT: NCT05116449 · 2019-A02397-50

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗