Increasing Access to Fertility Preservation for Women with Breast Cancer

NCT05989776 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Informational 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.

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV
  • Institut Claudius Regaud

    collaborator OTHER
  • Réseau Onco-Occitanie

    collaborator UNKNOWN
  • Réseau ONCOPL

    collaborator UNKNOWN
  • University Paul Sabatier of Toulouse

    lead OTHER

Principal Investigators

  • Marie-Anne Durand, PhD · Université Toulouse III Paul Sabatier

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05989776 on ClinicalTrials.gov