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

Breast Cancer Clinical Trial

— WEBAPPAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554927
• Other study ID #: WEBAPPAC
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: March 3, 2025

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 438
• Est. completion date: March 3, 2025
• Est. primary completion date: September 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hormono Therapy
• Web-application

Intervention

Other:
• WEB-Application
The patients of the Web-application arm will be trained on the devices and the application will be installed either on their smartphone or on another support (computer, tablet).
• Standard accompaniment
Personalized schedule of medical follow-up given to the patient

Locations

Country	Name	City	State
France	Centre François baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observance of hormontherapy	Evaluate the benefit of a web-based application on hormone therapy compliance (Morisky questionnary; answer Yes or No; 8 questions)	18 months
Secondary	Quality of life with self questionnaires	Quality of life scores according (EORTC QLQ-C30 self-questionnaires ; minimum not at all to maximum Lot; 30 questions)	18 months
Secondary	Quality of life with self questionnaires	uality of life scores according (EORTC QLQ-BR23 self-questionnaires ; minimum not at all to maximum Lot; 23 questions)	18 months