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Clinical Trials/NCT05116449
NCT05116449
Recruiting
Not Applicable

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

Ramsay Générale de Santé2 sites in 1 country310 target enrollmentFebruary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Ramsay Générale de Santé
Enrollment
310
Locations
2
Primary Endpoint
Quality of life questionnaire : FACT-B
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
January 22, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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

  • 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

Outcomes

Primary Outcomes

Quality of life questionnaire : FACT-B

Time Frame: 12 months

Functional Assessment of Cancer Therapy-breast : 27 items about physical well-being, family well-being, emotional and functional well-being. The quotation is between 0 "not at all" and 4 "verry much". The total score is between 0 and 148. The higher the scores, the higher the QoL and the various well-being.

Quality of life questionnaire : EORTC QLQ-C30

Time Frame: 12 months

30 items for all patient suffering from cancer. The answer of each question is between 1 "not at all" and 4 "very much"

Study Sites (2)

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