Breast CancerEVAPREFNCT05989776
Increasing Access to Fertility Preservation for Women with Breast Cancer
A study testing Informational brochure for patients and brief training for oncologists in people with Breast Cancer, run by University Paul Sabatier of Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Informational brochure for patients and brief training for oncologists
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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..
Who cannot join
- People whose mental health status precludes participation in the study, as determined by the clinical team.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Nantes
Nantes
Delphine Lauzeille, delphine.lauzeille@chu-nantes.fr
- Recruiting
Institut Claudius Regaud (IUCT-O)
Toulouse
Charlotte Morel, morel@onco-occitanie.frcopole.fr
About this study
Official title: Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Informational brochure for patients and brief training for oncologists
- Keywords
- Breast cancer, Fertility preservation, Information, Practitioner training, Social inequalities in health, Participatory approach, Combined intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational brochure for patients and brief training for oncologistsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Informational brochure for patients and brief training for oncologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 18 mont post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Institut Claudius Regaud, Réseau Onco-Occitanie, Réseau ONCOPL
- Responsible party
- Principal investigator, Marie-Anne Durand, University Paul Sabatier of Toulouse
- Investigators
- Marie-Anne Durand, PhD, Principal investigator, Université Toulouse III Paul Sabatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989776
- Sponsor's protocol ID
- 2022-057
- Acronym
- EVAPREF
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38243214
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation
- ClinicalTrials.gov ID
- NCT05989776
- Acronym / sponsor ID
- EVAPREF / 2022-057
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Fertility preservation, Information, Practitioner training, Social inequalities in health, Participatory approach, Combined intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Institut Claudius Regaud, Réseau Onco-Occitanie, Réseau ONCOPL
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will conduct a randomized stepped-wedge trial multi-site evaluating access to fertility preservation counseling over a 30-month period.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care information to fertility preservation counseling |
| Intervention: informational brochure for patients and brief training for oncologists | Active comparator | Behavioral: Informational brochure for patients and brief training for oncologistsThe intervention is based on information provided to different target populations, using a variety of media, including brochures and videos. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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..
Key exclusion criteria (1 listed)
- People whose mental health status precludes participation in the study, as determined by the clinical team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational brochure for patients and brief training for oncologistsFor 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. | Behavioural | Intervention: informational brochure for patients and brief training for oncologists |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 38243214Addamiano 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Anne Durand, PhD principal investigator
Université Toulouse III Paul Sabatier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational brochure for patients and brief training for oncologists in people with Breast Cancer, run by University Paul Sabatier of Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Anne Durand, PhD (0033648038356, marie-anne.durand@univ-tlse3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recourse to fertility preservation consultation before and after using the combined intervention (time frame: up to 18 mont post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05989776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.