Evidence map›Paper›PMID 38243214›Full record

ArticleBMC public health2024

Increasing access to fertility preservation for women with breast cancer: protocol for a stepped-wedge cluster randomized trial in France.

Maria Claudia Addamiano, Camille Joannes, Leslie Fonquerne, Charlotte Morel, Delphine Lauzeille, Lorène Belkadi, Fabienne Empereur, Pascale Grosclaude, Eric Bauvin, Cyrille Delpierre and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC public health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05989776 (Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05989776 narecruitingnot on this map

Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation

TypeinterventionalSponsorUniversity Paul Sabatier of ToulouseRan2022 to 2026Enrolled750ConditionsBreast CancerArmsInformational brochure for patients and brief training for oncologists
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Maria Claudia AddamianoEQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France.
Camille JoannesEQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France.
Leslie FonquerneEQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France.
Charlotte MorelRegional Cancer Network of Occitanie (Onco-Occitanie), Toulouse, France.
Delphine LauzeilleRegional Cancer Network of Pays de la Loire (Onco-PL), Nantes, France.
Lorène BelkadiRegional Cancer Network of Occitanie (Onco-Occitanie), Toulouse, France.
Fabienne EmpereurRegional Cancer Network of Pays de la Loire (Onco-PL), Nantes, France.
Pascale GrosclaudeEQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France.
Eric BauvinEQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France.
Cyrille DelpierreEQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France.
Sébastien Lamy *EQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France.
Marie-Anne Durand *EQUITY research team (Certified by the French League Against Cancer), CERPOP, UMR 1295, Université Toulouse III Paul Sabatier, Toulouse, France. marie-anne.durand@dartmouth.edu.

Funding

Institut National Du Cancer 2023-649R2
6 · The paper itself

Abstract

backgroundWith 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. Our overall goal is to improve access to fertility preservation consultations for women with breast cancer through the development and evaluation of a combined intervention targeting the access and diffusion of information for these patients and brief training for oncologists.

methodsFirstly, we will improve existing information tools and create brief training content for oncologists using a qualitative, iterative, user-centred and participatory approach (objective 1). We will then use these tools in a combined intervention to conduct a stepped-wedge cluster randomized trial (objective 2) including 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one of the 6 participating centers. As the primary outcome of the trial will be the access to fertility preservation counselling before and after using the combined intervention (brochures and brief training for oncologists), we will compare the rate of fertility preservation consultations between the usual care and intervention phases using linear regression models. Finally, we will analyse our approach using a context-sensitive implementation analysis and provide key elements for transferability to other contexts in France (objective 3). DISCUSSION: We expect to observe an increase in access to fertility preservation consultations as a result of the combined intervention. 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. The user-centred 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.

trial registrationRegistry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT05989776. Date of registration: 7 CLINICALTRIALS: gov/ct2/show/NCT05989776 . PROTOCOL VERSION: Manuscript based on study protocol version 2.0, 21st may 2023.

Indexed as

Breast NeoplasmsFertility PreservationCounselingFemaleFertilityHumansQuality of LifeRandomized Controlled Trials as TopicBreast cancerCombined interventionFertility preservationInformationParticipatory approachPractitioners trainingSocial inequalities in health

Identifiers

PMID38243214
PMCPMC10797742

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.