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Trial Title:
Increasing Access to Fertility Preservation for Women With Breast Cancer
NCT ID:
NCT05989776
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Fertility preservation
Information
Practitioner training
Social inequalities in health
Participatory approach
Combined intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Other
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Informational brochure for patients and brief training for oncologists
Description:
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.
Arm group label:
Intervention: informational brochure for patients and brief training for oncologists
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.
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 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.
Criteria for eligibility:
Criteria:
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 precludes participation in the study, as
determined by the clinical team.
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Nantes
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Contact:
Last name:
Delphine Lauzeille
Email:
delphine.lauzeille@chu-nantes.fr
Facility:
Name:
Institut Claudius Regaud (IUCT-O)
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Charlotte Morel
Email:
morel@onco-occitanie.frcopole.fr
Start date:
June 1, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
University Paul Sabatier of Toulouse
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute, France
Agency class:
Other
Collaborator:
Agency:
Institut Claudius Regaud
Agency class:
Other
Collaborator:
Agency:
Réseau Onco-Occitanie
Agency class:
Other
Collaborator:
Agency:
Réseau ONCOPL
Agency class:
Other
Source:
University Paul Sabatier of Toulouse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05989776
