NCT03591848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

July 9, 2018

Last Update Submit

March 3, 2026

Conditions

Breast Cancer

Keywords

Breast cancerPreservation of fertilityOnline support decision tool

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Decisional Conflict Scale Measure on

    1 day (at the end of the PF consultation)

  • Anxiety

    1 day ( at the end of the PF consultation)

Study Arms (2)

DECISIF

EXPERIMENTAL

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

Behavioral: Online support decision toolBehavioral: standard oral information

IRIS

ACTIVE COMPARATOR

Exposed to a standard oral information

Behavioral: standard oral information

Interventions

standard oral informationBEHAVIORAL

standard oral information

DECISIFIRIS
Online support decision toolBEHAVIORAL

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

DECISIF

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproduction medicine and fertility preservation ANTOINE BECLERE Hospital

Clamart, 92140, France

Location

Related Publications (1)

  • 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.

    PMID: 32047010RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michaël GRYNBERG, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

September 9, 2018

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)