Actively Recruiting
Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer According to Access to Supportive Oncological Care
Led by Ramsay Générale de Santé · Updated on 2025-09-17
310
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
Ramsay Générale de Santé
Lead Sponsor
E
European Clinical Trial Experts Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore the quality of life of women who have undergone surgery for invasive breast cancer. It focuses on how their quality of life changes throughout their care journey, especially considering their access to supportive oncological care both within and outside the healthcare facility. The study is observational and involves women who speak French and are covered by social security. Participants are assessed using various quality of life questionnaires, including FACT-B and EORTC QLQ-C30, among others. Women are grouped based on whether they seek supportive oncological care or do not receive any such care. The study monitors these groups over a 12-month period to compare changes in quality of life. During the study, participants will complete several questionnaires related to their quality of life at regular intervals up to 12 months. Researchers will collect and analyze this information to understand the impact of supportive care on patients' well-being. The study excludes women with metastatic or bilateral breast cancer, those with recent other cancers, or those unable to complete questionnaires or participate fully.
CONDITIONS
Brief 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 (IDSein)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman with histologically confirmed invasive breast cancer scheduled for surgery
- Age over 18 years
- ECOG performance status less than 2
- Ability to speak and understand French and complete questionnaires
- Affiliated with or beneficiary of a social security scheme
- Patient has read the information note and does not object to data use
You will not qualify if you...
- Male
- Metastatic breast cancer
- Bilateral breast cancer
- History of cancer within the last 5 years
- Active infection or serious condition preventing treatment
- History or progressive psychiatric illness
- Person deprived of liberty or under guardianship
- Unable to undergo medical monitoring due to geographic, social, or psychological reasons
- Emergency amputation indication
- Protected adult under legal guardianship or deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding, or parturient woman
- Hospitalized without consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants complete various quality of life questionnaires to assess their status over time.
Periodic questionnaire assessments over 12 months
Trial Site Locations
Total: 2 locations
1
Institut du sein Drôme Ardèche
Guilherand-Granges, France, 07500
Actively Recruiting
2
Hôpital Privé de l'Estuaire
Le Havre, France, 76620
Actively Recruiting
Research Team
J
Jean-François Oudet
M
Marie-Hélène Barba
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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