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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: standard oral information; Behavioral: Online support decision tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03591848

2017-A03008-45 (Registry Identifier)

K171005J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

DECISIF

Experimental group

Description:

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

Treatment:

Behavioral: Online support decision tool

Behavioral: standard oral information

IRIS

Active Comparator group

Description:

Exposed to a standard oral information

Treatment:

Behavioral: standard oral information