Quality of life after breast cancer surgery with or without supportive oncology care
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
See if having supportive oncology care during and after surgery improves quality of life for women with invasive breast cancer who are scheduled for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ramsay Générale de Santé Academic / other |
| Locations | 2 sites (Guilherand-Granges and 1 other locations) |
| Trial ID | NCT05116449 on ClinicalTrials.gov |
What this trial studies
This is an observational study following women with histologically confirmed invasive breast cancer who are scheduled for surgery to compare quality-of-life outcomes according to their access to supportive oncological care inside or outside the treatment center. Participants complete validated quality-of-life questionnaires at defined points during their care pathway to capture physical, emotional, and social wellbeing. Researchers will compare questionnaire results between patients with differing levels or timing of supportive care to identify associations. The study is conducted at participating French hospitals and requires participants to speak French and be able to complete written questionnaires.
Who should consider this trial
Good fit: Women aged over 18 with histologically confirmed, non-metastatic, unilateral invasive breast cancer scheduled for surgery, ECOG performance status <2, who speak French and can complete questionnaires are ideal candidates.
Not a fit: Patients with metastatic or bilateral breast cancer, a recent other cancer within five years, active serious illness, progressive psychiatric disease, legal protection/deprivation of liberty, or those unable to complete follow-up or questionnaires are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could encourage wider provision or better timing of supportive oncology services to improve postoperative recovery and overall wellbeing for breast cancer patients.
How similar studies have performed: Previous studies of psycho-social and supportive oncology interventions in breast cancer populations have reported improvements in quality of life, so this approach builds on existing evidence rather than being entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guilherand-Granges and 1 other locations
- Institut du sein Drôme Ardèche — Guilherand-Granges, France (Recruiting)
- Hôpital Privé de l'Estuaire — Le Havre, France (Recruiting)
Study contacts
- Study coordinator: Jean-François Oudet
- Email: jf.oudet@ecten.eu
- Phone: 0683346567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.