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RecruitingNCT05116449IDSeinUpdated Sep 17, 2025

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)

An observational study in Breast Cancer Female, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
310
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer Female
03

In context

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women patient with breast cancer

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
310 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient seeking supportive care

    Behavioral: Quality of life questionnaires

  • Patient without any supportive care

    Behavioral: Quality of life questionnaires

Interventions

  • BehavioralQuality of life questionnaires

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

06

What researchers measure

Primary outcomes

  1. Quality of life questionnaire : FACT-B

    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.

    Time frame: 12 months

  2. Quality of life questionnaire : EORTC QLQ-C30

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

    Time frame: 12 months

07

Study locations

2 of 2 sites recruiting
  • Institut du sein Drôme Ardèche
    Guilherand-Granges, 07500, France
    Recruiting
  • Hôpital Privé de l'Estuaire
    Le Havre, 76620, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05116449
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators
European Clinical Trial Experts Network
Responsible party
Sponsor
First posted
Nov 11, 2021
Start date
Feb 22, 2021
Primary completion
Dec 22, 2025 (estimated)
Completion
Jan 22, 2026 (estimated)
Last update
Sep 17, 2025

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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