Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer

Not Applicable

Recruiting

• Conditions: Hormono Therapy; Web-application; Breast Cancer
• Interventions: Other: WEB-Application; Other: Standard accompaniment

• Registration Number: NCT04554927
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

The investigators hypothesize that the implementation of a Web-application in patients initiating adjuvant hormone therapy for breast cancer brings a benefit on treatment adherence and quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-03
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-11
• Study Completion: 2025-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 438

Inclusion Criteria

• Patient > 18 years old
• Breast cancer patient candidate for adjuvant hormone therapy
• Mastery of the French language
• Patient with a cell phone and an Internet connection
• Patient able to use a computer, smartphone, or tablet.
• Patient affiliated to a social security system
• Signing of informed consent prior to any specific study-related procedure

Exclusion Criteria

• Patient who has previously received hormone therapy for cancer.
• Patient not trained in the use of the application
• Any associated medical or psychiatric condition that might compromise the patient's ability to participate in the study
• Patients with locoregional or metastatic recurrence
• Other history of cancer.
• Patient deprived of liberty, under guardianship or curatorship
• Simultaneous participation in a therapeutic clinical trial or other clinical study involving a connected tool
• Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WEB-application	WEB-Application	-
Standard accompaniment	Standard accompaniment	-

Primary Outcome Measures

Name	Time	Method
Observance of hormontherapy	18 months	Evaluate the benefit of a web-based application on hormone therapy compliance (Morisky questionnary; answer Yes or No; 8 questions)

Secondary Outcome Measures

Name	Time	Method
Quality of life with self questionnaires	18 months	uality of life scores according (EORTC QLQ-BR23 self-questionnaires ; minimum not at all to maximum Lot; 23 questions)

Trial Locations

Locations (1)

Centre François baclesse; 🇫🇷 Caen, France