Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility (DECISIF)
Evaluation of an Online Decision Support Tool for Young Women With Breast Cancer During the Proposal for Preservation of Fertility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In recent decades, the incidence of breast cancer has increased significantly among young women. Between 1980 and 2012, there was an increase of 59% and 53% in the 30-39 age group and the 40-49 age group, respectively. However, both diagnostic and therapeutic advances made it possible to significantly reduce mortality, at the cost of potentially deleterious chemotherapeutic treatments for reproductive function. These treatments may therefore be the cause of a chronic pathology "infertility" that may negatively impact the quality of life of young breast cancer survivors.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Clamart, France, 92140
- Reproduction medicine and fertility preservation ANTOINE BECLERE Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-40 years women
- with breast cancer
- cancer treatment not started, no antecedent of chemotherapy
- speaking French
- affiliated in Social Insurance
Exclusion Criteria:
- recurrence of breast cancer
- metastatic breast cancer
- pregnancy in progress
- Adults protected (wardship, guardianship, protection of justice)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DECISIF
Exposed to an online support decision tool, in addition of the standard oral information
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Online support decision tool, in addition of the standard oral information
standard oral information
|
|
Active Comparator: IRIS
Exposed to a standard oral information
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standard oral information
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional Measure of Informed Choice (MMIC)
Time Frame: 1 day (During the PF consultation)
|
Measure of patient autonomy for making decision, according to the Multidimensional Measure of Informed Choice (MMIC). A series of closed questions (based on the Osgoog's scale) on their feelings about this fertility preservation approach, describing attitudes in regards to "good / bad", "important / unimportant", "unhelpful" good thing / bad thing, "" pleasant / unpleasant "and" useful / useless ". Responses go from "very positive" (1) to "very negative" (7). |
1 day (During the PF consultation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decisional Conflict Scale Measure on
Time Frame: 1 day (at the end of the PF consultation)
|
patient's decision-making discomfort, specific support needs for decision-making, the quality of decision making, the impact of supportive interventions on health decision-making.
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1 day (at the end of the PF consultation)
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|
Anxiety
Time Frame: 1 day ( at the end of the PF consultation)
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: the 6 items of State and Trait Anxiety Inventory [55] [56], a reliable and sensitive measure of anxiety will be used to assess emotional disturbance.
It consists of 6 items, indicating the lowest level of anxiety (1 = not at all) and 4 the highest (4 = very much), with a reverse rating items.
The items are summated multiplied by 20 and divided by 6. Patients with scores> 50 are considered to have a high level of anxiety.
|
1 day ( at the end of the PF consultation)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michaël GRYNBERG, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K171005J
- 2017-A03008-45 (Registry Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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