Supportive care program for patients with non-metastatic breast cancer undergoing hormone therapy
Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique
NA · Centre Hospitalier Emile Roux · NCT04794075
This study is testing a supportive care program that combines education and phone check-ins to see if it helps women with non-metastatic breast cancer feel better while they are on hormone therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Emile Roux (other) |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Bourg-en-Bresse and 8 other locations) |
| Trial ID | NCT04794075 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a therapeutic education program combined with nursing support via phone follow-ups for patients receiving hormone therapy for non-metastatic breast cancer. The goal is to manage adverse events related to hormone therapy and enhance the quality of life for these patients during the first year of treatment. By providing personalized care and active listening, the program seeks to improve overall patient outcomes compared to conventional management alone.
Who should consider this trial
Good fit: Ideal candidates are patients with non-metastatic breast cancer who are about to start adjuvant hormone therapy and can understand French.
Not a fit: Patients with metastatic cancer or those who have previously undergone hormone therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the management of side effects from hormone therapy, leading to better quality of life for patients.
How similar studies have performed: Other studies have shown positive outcomes with similar supportive care approaches, indicating potential for success in this program.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18 to 75 years inclusive * Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting. * Performance status (ECOG) ≤ 2 * Patient able to read and understand French (common use) * Patient with access to an internet connection (for collection of adverse events and responses to questionnaires on the electronic platform) * Patient who has been informed and has given written consent to participate in the study * Patient affiliated to the French social security system or equivalent Exclusion Criteria: * Patient with metastatic cancer (stage IV) * Patient undergoing neoadjuvant hormone therapy * Patient who started hormone therapy prior to inclusion in the study * Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago. * For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for geographical, physical or other reasons (at the discretion of the investigator). * For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education. * Pregnant and breastfeeding women * Patient with a documented history of cognitive or psychiatric disorders * Refusal to participate, protected adult patient, under guardianship or curatorship
Where this trial is running
Bourg-en-Bresse and 8 other locations
- Centre Hospitalier de Bourg-en-Bresse / Fleyriat — Bourg-en-Bresse, France (RECRUITING)
- Clinique De L'infirmerie Protestante De Lyon — Caluire-et-Cuire, France (RECRUITING)
- CH de Carcassonne — Carcassonne, France (RECRUITING)
- CHAL - Centre Hospitalier Alpes Léman — Contamine-sur-Arve, France (NOT_YET_RECRUITING)
- Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (RECRUITING)
- Centre Hospitalier François Quesnay — Mantes-la-Jolie, France (RECRUITING)
- Groupement Hospitalier Portes de Provence — Montélimar, France (NOT_YET_RECRUITING)
- Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord — Saint-Priest-en-Jarez, France (RECRUITING)
- Médipôle Lyon-Villeurbanne — Villeurbanne, France (RECRUITING)
Study contacts
- Principal investigator: Séverine Breysse — Centre Hospitalier Emile Roux
- Study coordinator: Émilie GADEA, PhD
- Email: projetetaph@ch-lepuy.fr
- Phone: +33 4 71 04 35 38
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.
Conditions: Neoplasm of Breast, Therapeutic Education, Nursing Support Program, Hormone Therapy, Non-metastatic Breast Cancer, Breast Cancer