Increasing Access to Fertility Preservation for Women with Breast Cancer

NCT05989776 | Recruiting

• 1 other identifier: 2022-057
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer

Keywords

Breast cancer; Fertility preservation; Information; Practitioner training; Social inequalities in health; Participatory approach; Combined intervention

Outcome Measures

Primary Outcomes (1)

• Rate of recourse to fertility preservation consultation before and after using the combined intervention

  This information will be collected by each regional screening coordination center of the two participating regions from the medical records of patients

  up to 18 mont post enrollment

Study Arms (2)

Usual care

NO INTERVENTION

Usual care information to fertility preservation counseling

Intervention: informational brochure for patients and brief training for oncologists

ACTIVE COMPARATOR

The intervention is based on information provided to different target populations, using a variety of media, including brochures and videos.

Behavioral: Informational brochure for patients and brief training for oncologists

Interventions

Informational brochure for patients and brief training for oncologists BEHAVIORAL

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.

Intervention: informational brochure for patients and brief training for oncologists

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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..

You may not qualify if:

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

Sponsors & Collaborators

• University Paul Sabatier of Toulouse: lead
• National Cancer Institute, France: collaborator
• Institut Claudius Regaud: collaborator
• Réseau Onco-Occitanie: collaborator
• Réseau ONCOPL: collaborator

Study Sites (2)

CHU Nantes

Nantes, France

RECRUITING

Institut Claudius Regaud (IUCT-O)

Toulouse, France

RECRUITING

Related Publications (1)

• Addamiano MC, Joannes C, Fonquerne L, Morel C, Lauzeille D, Belkadi L, Empereur F, Grosclaude P, Bauvin E, Delpierre C, Lamy S, Durand MA. Increasing access to fertility preservation for women with breast cancer: protocol for a stepped-wedge cluster randomized trial in France. BMC Public Health. 2024 Jan 19;24(1):231. doi: 10.1186/s12889-024-17719-3.

  PMID: 38243214 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Oncologists

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Marie-Anne Durand, PhD

  Université Toulouse III Paul Sabatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Anne Durand, PhD

CONTACT

0033648038356; marie-anne.durand@univ-tlse3.fr

Sébastien Lamy, PhD

CONTACT

0033684449479; lamy.sebastien@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: The investigators will conduct a randomized stepped-wedge trial multi-site evaluating access to fertility preservation counseling over a 30-month period.

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 14, 2023
• Study Start: June 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

FR (2)