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

• ClinicalTrials.gov Identifier: NCT04554927
• Recruitment Status: Recruiting
• First Posted: September 18, 2020
• Last Update Posted: February 17, 2022
• Sponsor: Centre Francois Baclesse
• Information provided by (Responsible Party): Centre Francois Baclesse

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Web-application; Breast Cancer; Hormono Therapy	Other: WEB-Application; Other: Standard accompaniment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 438 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: September 3, 2020
• Estimated Primary Completion Date: September 3, 2022
• Estimated Study Completion Date: March 3, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: WEB-application	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).
Active Comparator: Standard accompaniment	Other: Standard accompaniment; Personalized schedule of medical follow-up given to the patient

Outcome Measures

Primary Outcome Measures :

1. Observance of hormontherapy [ Time Frame: 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 :

1. Quality of life with self questionnaires [ Time Frame: 18 months ]
   Quality of life scores according (EORTC QLQ-C30 self-questionnaires ; minimum not at all to maximum Lot; 30 questions)
2. Quality of life with self questionnaires [ Time Frame: 18 months ]
   uality of life scores according (EORTC QLQ-BR23 self-questionnaires ; minimum not at all to maximum Lot; 23 questions)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

Centre François baclesse; Recruiting

Caen, France, 14000

Contact: François GERNIER, Study nurse + 33 2 31 45 50 50 f.gernier@baclesse.unicancer.fr

Contact: Jean-Michel GRELLARD, project manager + 33 2 31 45 50 50 jm.grellard@baclesse.unicancer.fr

Principal Investigator: François GERNIER, Study nurse

Sub-Investigator: Gaelle ANNE, Study nurse

Sub-Investigator: Charlotte CEINTRE, Study nurse

Sub-Investigator: Rose-Marie CHARLES, Study nurse

Sub-Investigator: Audrey FAVEYRIAL, MD

Sub-Investigator: Christelle LEVY, MD

Sub-Investigator: Emile GEORGE, MD

Sub-Investigator: Djelila ALLOUACHE, MD

Sub-Investigator: Julien GEFFRELOT, MD

Sub-Investigator: Carine SEGURA, MD

Sub-Investigator: Katharina GUNZER, MD

Sub-Investigator: Ioana HRAB, MD

Sub-Investigator: Alison JOHNSON, MD

Sub-Investigator: Adeline MOREL, MD

Sponsors and Collaborators

Centre Francois Baclesse

More Information

• Responsible Party: Centre Francois Baclesse
• ClinicalTrials.gov Identifier: NCT04554927
• Other Study ID Numbers: WEBAPPAC
• First Posted: September 18, 2020
• Last Update Posted: February 17, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases