RecruitingNot ApplicableNCT05989776

Increasing Access to Fertility Preservation for Women with Breast Cancer

Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation

Sponsor

University Paul Sabatier of Toulouse

Enrollment

750 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria3

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 Criteria1

People whose mental health status precludes participation in the study, as determined by the clinical team.

Interventions

BEHAVIORALInformational brochure for patients and brief training for oncologists

For this randomized, stepped wedge trial, the investigators planned a mixed intervention that targets both health professionals and patients. This intervention will be carried out in its entirety thanks to the working groups made up of health professionals and expert patients that took place before the randomized trial. The intervention for health professionals consists of awareness training. They will be trained (or made aware) at different times, defined by randomization. The intervention for patients consists of a pictorial information brochure and tabular patient decision aid given by trained health professionals.