EVAPREF: Increasing Access to Fertility Preservation for Women With Breast Cancer

Sponsor
University Paul Sabatier of Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05989776
Collaborator
National Cancer Institute, France (Other), Institut Claudius Regaud (Other), Réseau Onco-Occitanie (Other), Réseau ONCOPL (Other)
750
2
2
49
375
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Study Details

Study Description

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 years of age and newly treated with chemotherapy for breast cancer, evaluating 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Informational brochure for patients and brief training for oncologists
N/A

Detailed Description

Background :

With the increase in the number of long-term survivors, interest is shifting from cancer survival to life and quality of life after cancer. These include consequences of long-term side effects of treatment, such as gonadotoxicity. Fertility preservation is becoming increasingly important in cancer management. International recommendations agree on the need to inform patients prior to treatments about the risk of fertility impairment and refer them to specialized centers to discuss fertility preservation. However, the literature reveals suboptimal access to fertility preservation on an international scale, and particularly in France, making information for patients and oncologists a potential lever for action. The overall goal is to improve access to fertility preservation and related consultations for women with breast cancer through the development and evaluation of a combined intervention targeting the diffusion of information for these patients and brief training for oncologists.

Methods :

First, the investigators will use a qualitative, iterative, user-centered and participatory approach to improve existing information tools and create training content for oncologists (Aim 1). Second, the investigators will conduct a randomized stepped-wedge trial evaluating rate of fertility preservation consultation over a 30-month period (Aim 2). The investigators will include 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one of the 6 participating centers. The primary outcome will be rate of fertility preservation consultation before and after using the combined intervention (informational brochure for patients and brief training for oncologists) and will be analyzed using linear regression models.Third, the investigators will analyze their approach (context-sensitive implementation analysis) and provide key elements for transferability to other contexts in France (Aim 3).

Discussion :

After transitioning to the combined intervention, the investigators will expect to observe an increase in access to fertility preservation consultation. Particular attention will be paid to the effect of this intervention on socially disadvantaged women, who are known to be at greater risk of inappropriate treatment. In addition, the user-centric design principles and participatory approaches used to optimize the acceptability, usability and feasibility of the combined intervention will likely enhance its impact, diffusion and sustainability.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The investigators will conduct a randomized stepped-wedge trial multi-site evaluating access to fertility preservation counseling over a 30-month period.The investigators will conduct a randomized stepped-wedge trial multi-site evaluating access to fertility preservation counseling over a 30-month period.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation
Actual Study Start Date :
Oct 31, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: Informational brochure for patients and brief training for oncologists
For this randomized, stepwise 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 sensitized) at different times, defined by randomization. The intervention for patients consists of information given by health professionals and improved information brochures.

Outcome Measures

Primary Outcome Measures

  1. Rate of recourse to fertility preservation consultation before and after using the combined intervention [up to 18 mont post enrollment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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 Criteria:
  • People whose mental health status does preclude participation in the study, as determined by their qualified staff.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nantes Nantes France
2 Institut Claudius Regaud (IUCT-O) Toulouse France

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Marie-Anne Durand, PhD, Université Toulouse III Paul Sabatier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie-Anne Durand, Researcher, University Paul Sabatier of Toulouse
ClinicalTrials.gov Identifier:
NCT05989776
Other Study ID Numbers:
  • 2022-057
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marie-Anne Durand, Researcher, University Paul Sabatier of Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023