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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)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05116449
Acronym
IDSein
Enrollment
310
Registered
2021-11-11
Start date
2021-02-22
Completion date
2026-01-22
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

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.

Interventions

BEHAVIORALQuality of life questionnaires

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

Sponsors

European Clinical Trial Experts Network
CollaboratorOTHER
Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life questionnaire : FACT-B12 monthsFunctional 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.
Quality of life questionnaire : EORTC QLQ-C3012 months30 items for all patient suffering from cancer. The answer of each question is between 1 not at all and 4 very much

Countries

France

Contacts

Primary ContactJean-François Oudet
jf.oudet@ecten.eu0683346567
Backup ContactMarie-Hélène Barba
mh.barba@ecten.eu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026