Increasing Access to Fertility Preservation for Women With Breast Cancer (EVAPREF)
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| ClinicalTrials.gov Identifier: NCT05989776 |
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Recruitment Status :
Recruiting
First Posted : August 14, 2023
Last Update Posted : September 7, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Behavioral: Informational brochure for patients and brief training for oncologists | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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. |
| Masking: | Single (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 : | June 1, 2022 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2026 |
| Arm | Intervention/treatment |
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No Intervention: Usual care
Usual care information to fertility preservation counseling
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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.
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Behavioral: 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. |
- Rate of recourse to fertility preservation consultation before and after using the combined intervention [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| 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 precludes participation in the study, as determined by the clinical team.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989776
| Contact: Marie-Anne Durand, PhD | 0033648038356 | marie-anne.durand@univ-tlse3.fr | |
| Contact: Sébastien Lamy, PhD | 0033684449479 | lamy.sebastien@iuct-oncopole.fr |
| France | |
| CHU Nantes | Recruiting |
| Nantes, France | |
| Contact: Delphine Lauzeille delphine.lauzeille@chu-nantes.fr | |
| Institut Claudius Regaud (IUCT-O) | Recruiting |
| Toulouse, France | |
| Contact: Charlotte Morel morel@onco-occitanie.frcopole.fr | |
| Principal Investigator: | Marie-Anne Durand, PhD | Université Toulouse III Paul Sabatier |
| Responsible Party: | Marie-Anne Durand, Researcher, University Paul Sabatier of Toulouse |
| ClinicalTrials.gov Identifier: | NCT05989776 |
| Other Study ID Numbers: |
2022-057 |
| First Posted: | August 14, 2023 Key Record Dates |
| Last Update Posted: | September 7, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Breast cancer Fertility preservation Information Practitioner training |
Social inequalities in health Participatory approach Combined intervention |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |