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)

NCT05116449 | Recruiting

• 1 other identifier: 2019-A02397-50
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• 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"

  12 months

Study Arms (2)

Patient seeking supportive care

Behavioral: Quality of life questionnaires

Patient without any supportive care

Behavioral: Quality of life questionnaires

Interventions

Quality of life questionnaires BEHAVIORAL

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

Patient seeking supportive care; Patient without any supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women patient with breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (2)

Institut du sein Drôme Ardèche

Guilherand-Granges, 07500, France

RECRUITING

Hôpital Privé de l'Estuaire

Le Havre, 76620, France

RECRUITING

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 11, 2021
• Study Start: February 22, 2021
• Primary Completion: December 22, 2025
• Study Completion: January 22, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

FR (2)