Improving fertility preservation access for women with breast cancer
Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation
NA · University Paul Sabatier of Toulouse · NCT05989776
This study tests new ways to help women under 40 with breast cancer get better access to fertility preservation options before they start chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University Paul Sabatier of Toulouse (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Nantes and 1 other locations) |
| Trial ID | NCT05989776 on ClinicalTrials.gov |
What this trial studies
The EVAPREF project aims to enhance access to fertility preservation for women under 40 newly diagnosed with breast cancer undergoing chemotherapy. It employs a user-centered approach to improve existing information and coordination tools, alongside training for oncologists. The study will evaluate the effectiveness of these tools through a randomized stepped wedge trial over a 30-month period, assessing the rate of fertility preservation consultations before and after implementation. Additionally, the project will analyze the context-sensitive implementation of the approach to facilitate its transferability to other regions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 who are newly diagnosed with breast cancer and are set to receive chemotherapy.
Not a fit: Patients whose mental health status prevents them from participating in the study will not benefit from this intervention.
Why it matters
Potential benefit: If successful, this project could significantly improve the awareness and access to fertility preservation options for young women facing breast cancer treatment.
How similar studies have performed: While there is existing literature on fertility preservation, this approach is innovative in its focus on improving information dissemination and oncologist training, making it a novel initiative.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 and under 40 years of age treated for newly diagnosed breast cancer and receiving chemotherapy. * People who are able to read the study information poster and the fertility preservation information brochure in French, either alone or with help from a caregiver or relative or an interpreter. * People with intellectual disability will be included as long as they are able able to read the study information poster and the fertility preservation information brochure in French alone or with help from a caregiver or relative or an interpreter.. Exclusion Criteria: * People whose mental health status precludes participation in the study, as determined by the clinical team.
Where this trial is running
Nantes and 1 other locations
- CHU Nantes — Nantes, France (RECRUITING)
- Institut Claudius Regaud (IUCT-O) — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Marie-Anne Durand, PhD — Université Toulouse III Paul Sabatier
- Study coordinator: Marie-Anne Durand, PhD
- Email: marie-anne.durand@univ-tlse3.fr
- Phone: 0033648038356
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: Breast Cancer, Breast cancer, Fertility preservation, Information, Practitioner training, Social inequalities in health, Participatory approach, Combined intervention