Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility

Breast Cancer Clinical Trial

— DECISIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591848
• Other study ID #: K171005J
• Secondary ID: 2017-A03008-45
• Status: Completed
• Phase: N/A
• Start date: September 9, 2018
• Est. completion date: March 17, 2020

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Online support decision tool
Online support decision tool, in addition of the standard oral information
• standard oral information
standard oral information

Locations

Country	Name	City	State
France	Reproduction medicine and fertility preservation ANTOINE BECLERE Hospital	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional Measure of Informed Choice (MMIC)	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	Decisional Conflict Scale Measure on	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.	1 day (at the end of the PF consultation)
Secondary	Anxiety	: 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)