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)

Breast Cancer Female Clinical Trial

— IDSein  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116449
• Other study ID #: 2019-A02397-50
• Status: Recruiting
• Start date: February 22, 2021
• Est. completion date: August 22, 2023

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: August 22, 2023
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 treated with neoadjuvant chemotherapy
• Patient participating in a therapeutic trial
• 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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut du sein Drôme Ardèche	Guilherand-Granges

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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