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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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..

Locations
Other Locations
France
CHU Nantes
RECRUITING
Nantes
Institut Claudius Regaud (IUCT-O)
RECRUITING
Toulouse
Contact Information
Primary
Marie-Anne Durand, PhD
marie-anne.durand@univ-tlse3.fr
0033648038356
Backup
Sébastien Lamy, PhD
lamy.sebastien@iuct-oncopole.fr
0033684449479
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 750
Treatments
No_intervention: Usual care
Usual care information to fertility preservation counseling
Active_comparator: Intervention: informational brochure for patients and brief training for oncologists
The intervention is based on information provided to different target populations, using a variety of media, including brochures and videos.
Related Therapeutic Areas
Sponsors
Leads: University Paul Sabatier of Toulouse
Collaborators: Réseau ONCOPL, Réseau Onco-Occitanie, National Cancer Institute, France, Institut Claudius Regaud

This content was sourced from clinicaltrials.gov