NCT05989776 Increasing Access to Fertility Preservation for Women with Breast Cancer
| NCT ID | NCT05989776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Paul Sabatier of Toulouse |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2022-06-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The EVAPREF project aims to increase access to fertility preservation by developing an approach to improve and evaluate existing information and coordination tools developed by the Pays-de-la-Loire and Occitanie Regional Cancer networks. First, the investigators will use a qualitative, iterative, user-centered and participatory approach to improve the current tools and create training content for the physicians who will use these tools. Second, the investigators will conduct a randomized stepped wedge trial of women under 40 newly treated with chemotherapy for breast cancer. The investigators will evaluate the rate of fertility preservation consultation before and after implementation of the improved tools, over a 30-month period from mid-2023 to the end of 2025. Finally, in a third step, the investigators will study their approach (context-sensitive implementation analysis) and provide key elements for its transferability to other contexts and in particular to other Regional Cancer networks in France.
Eligibility 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.
Contact & Investigator
Marie-Anne Durand, PhD
PRINCIPAL INVESTIGATOR
Université Toulouse III Paul Sabatier
Frequently Asked Questions
Who can join the NCT05989776 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989776 currently recruiting?
Yes, NCT05989776 is actively recruiting participants. Contact the research team at marie-anne.durand@univ-tlse3.fr for enrollment information.
Where is the NCT05989776 trial being conducted?
This trial is being conducted at Nantes, France, Toulouse, France.
Who is sponsoring the NCT05989776 clinical trial?
NCT05989776 is sponsored by University Paul Sabatier of Toulouse. The principal investigator is Marie-Anne Durand, PhD at Université Toulouse III Paul Sabatier. The trial plans to enroll 750 participants.
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