Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT05989776

Increasing Access to Fertility Preservation for Women with Breast Cancer

Led by University Paul Sabatier of Toulouse · Updated on 2024-12-12

750

Participants Needed

2

Research Sites

234 weeks

Total Duration

On this page

Sponsors

U

University Paul Sabatier of Toulouse

Lead Sponsor

N

National Cancer Institute, France

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Increasing Access to Fertility Preservation for Women with Breast Cancer

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 and under 40 years of age treated for newly diagnosed breast cancer and receiving chemotherapy.
  • Able to read the study information poster and fertility preservation brochure in French, alone or with help from a caregiver, relative, or interpreter.
  • People with intellectual disability can participate if able to read the study information and brochure in French, alone or with help.
Not Eligible

You will not qualify if you...

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

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Trial Site Locations

Total: 2 locations

1

CHU Nantes

Nantes, France

Actively Recruiting

2

Institut Claudius Regaud (IUCT-O)

Toulouse, France

Actively Recruiting

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Research Team

M

Marie-Anne Durand, PhD

CONTACT

S

Sébastien Lamy, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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