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临床试验/NCT03591848
NCT03591848已完成不适用

Evaluation of an Online Decision Support Tool for Young Women With Breast Cancer During the Proposal for Preservation of Fertility

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2018年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
1
主要终点
Multidimensional Measure of Informed Choice (MMIC)

研究概览

简要总结

Comparative study of two information modalities during the care course, aiming to propose the preservation of fertility to young women with breast cancer (but not yet under treatment): standard oral information during the PF consultation vs. an online decision support tool, consulted prior to the PF consultation, during which the standard oral information is provided.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-40 years women
  • with breast cancer
  • cancer treatment not started, no antecedent of chemotherapy
  • speaking French
  • affiliated in Social Insurance

排除标准

  • recurrence of breast cancer
  • metastatic breast cancer
  • pregnancy in progress
  • Adults protected (wardship, guardianship, protection of justice)

研究组 & 干预措施

DECISIF

Experimental

Exposed to an online support decision tool, in addition of the standard oral information

干预措施: Online support decision tool (Behavioral)

DECISIF

Experimental

Exposed to an online support decision tool, in addition of the standard oral information

干预措施: standard oral information (Behavioral)

IRIS

Active Comparator

Exposed to a standard oral information

干预措施: standard oral information (Behavioral)

结局指标

主要结局

Multidimensional Measure of Informed Choice (MMIC)

时间窗: 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).

次要结局

  • Decisional Conflict Scale Measure on(1 day (at the end of the PF consultation))
  • Anxiety(1 day ( at the end of the PF consultation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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