Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
NCT ID: NCT03591848
Last Updated: 2025-09-12
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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COMPLETED
NA
186 participants
INTERVENTIONAL
2018-09-09
2020-03-17
Brief Summary
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Detailed Description
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Since 2004, in France, the preservation of fertility (PF) is part of the different laws of bioethics. The latest cancer plans have highlighted the importance of quality of life in patients cured of cancer. For young women, this often involves the possibility of accessing maternity, using their own gametes. Thus, access to an onco fertility consultation should be systematically proposed, ideally before the initiation of any cancer treatment.
While the importance of oncofertility consultations is now recognized, they raise a certain number of ethical questions, particularly as to the nature of the information to be transmitted, whether it is generalizable or not, and how it is delivered and supported.
Very little data on the value of decision support tools in PF for women with breast cancer are available, while the concept of "shared medical decision" is becoming increasingly important in the doctor-patient relationship.
The only available studies have shown that these tools can reduce the level of decisional conflict and regret over fertility-related treatment options, and improve knowledge about fertility and satisfaction among young women.
This study aims to compare two modalities of delivery of information to breast cancer patients (not yet under treatment): standard oral information during the prevention of fertility (PF) consultation vs. an online decision support tool, consulted prior to the PF consultation, during which the standard oral information is provided.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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DECISIF
Exposed to an online support decision tool, in addition of the standard oral information
Online support decision tool
Online support decision tool, in addition of the standard oral information
standard oral information
standard oral information
IRIS
Exposed to a standard oral information
standard oral information
standard oral information
Interventions
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Online support decision tool
Online support decision tool, in addition of the standard oral information
standard oral information
standard oral information
Eligibility Criteria
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Inclusion Criteria
* with breast cancer
* cancer treatment not started, no antecedent of chemotherapy
* speaking French
* affiliated in Social Insurance
Exclusion Criteria
* metastatic breast cancer
* pregnancy in progress
* Adults protected (wardship, guardianship, protection of justice)
18 Years
40 Years
FEMALE
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Michaël GRYNBERG, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Reproduction medicine and fertility preservation ANTOINE BECLERE Hospital
Clamart, , France
Countries
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References
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Benoit A, Grynberg M, Morello R, Sermondade N, Grandazzi G, Moutel G. Does a web-based decision aid improve informed choice for fertility preservation in women with breast cancer (DECISIF)? Study protocol for a randomised controlled trial. BMJ Open. 2020 Feb 10;10(2):e031739. doi: 10.1136/bmjopen-2019-031739.
Other Identifiers
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2017-A03008-45
Identifier Type: REGISTRY
Identifier Source: secondary_id
K171005J
Identifier Type: -
Identifier Source: org_study_id
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