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) (IDSein)

September 11, 2025 updated by: Ramsay Générale de Santé

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Guilherand-Granges, France, 07500
        • Recruiting
        • Institut du sein Drôme Ardèche
        • Contact:
        • Contact:
      • Le Havre, France, 76620
        • Recruiting
        • Hopital Prive de l'Estuaire
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women patient with breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient seeking supportive care
Behavioral: Quality of life questionnaires
Different quality of life questionnaires : FACT-B, EORTC QLQ-C30, QIC, BRIEF COPE, HADS, QSSS-C
Patient without any supportive care
Behavioral: Quality of life questionnaires
Different quality of life questionnaires : FACT-B, EORTC QLQ-C30, QIC, BRIEF COPE, HADS, QSSS-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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"
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Estimated)

December 22, 2025

Study Completion (Estimated)

January 22, 2026

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02397-50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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