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NCT Number: 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)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut du sein Drôme Ardèche, Guilherand-Granges, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life questionnaires

Behavioral

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

Primary outcomes

  1. 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.

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Jean-François Oudet

CONTACT

[email protected]

0683346567

Marie-Hélène Barba

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • European Clinical Trial Experts Network

Registry information

Official study 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

Acronym: IDSein

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 11, 2021
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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