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)

NCT ID: NCT05116449

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2026-01-22

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient seeking supportive care

Quality of life questionnaires

Intervention Type BEHAVIORAL

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

Patient without any supportive care

Quality of life questionnaires

Intervention Type BEHAVIORAL

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

Interventions

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Quality of life questionnaires

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut du sein Drôme Ardèche

Guilherand-Granges, , France

Site Status RECRUITING

Hôpital Privé de l'Estuaire

Le Havre, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

0683346567

Marie-Hélène Barba

Role: CONTACT

Facility Contacts

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Jean-François Oudet

Role: primary

0683346567

Marie-Hélène Barba

Role: backup

Valérie Riquier, Dr

Role: primary

00332 76 89 95 84

Other Identifiers

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2019-A02397-50

Identifier Type: -

Identifier Source: org_study_id

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