Increasing Access to Fertility Preservation for Women with Breast Cancer
NCT ID: NCT05989776
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
750 participants
INTERVENTIONAL
2022-06-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Usual care
Usual care information to fertility preservation counseling
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Institut Claudius Regaud
OTHER
Réseau Onco-Occitanie
UNKNOWN
Réseau ONCOPL
UNKNOWN
University Paul Sabatier of Toulouse
OTHER
Responsible Party
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Marie-Anne Durand
Researcher
Principal Investigators
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Marie-Anne Durand, PhD
Role: PRINCIPAL_INVESTIGATOR
Université Toulouse III Paul Sabatier
Locations
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CHU Nantes
Nantes, , France
Institut Claudius Regaud (IUCT-O)
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Delphine Lauzeille
Role: primary
Charlotte Morel
Role: primary
References
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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.
Other Identifiers
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2022-057
Identifier Type: -
Identifier Source: org_study_id