Increasing Access to Fertility Preservation for Women with Breast Cancer

Recruiting · NCT05989776 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

Informational brochure for patients and brief training for oncologists

What this trial is about

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.

Who can take part

Age range

18 Years to 40 Years

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 it is running

2 locations listed.

CHU Nantes - Nantes, France
Institut Claudius Regaud (IUCT-O) - Toulouse, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →