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

July 31, 2023 updated by: Centre Francois Baclesse
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

438

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • Centre Francois Baclesse
        • Contact:
        • Contact:
        • 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:
          • Emile GEORGE, MD
        • Sub-Investigator:
          • Christelle LEVY, MD
        • Sub-Investigator:
          • Adeline MOREL, MD
        • Sub-Investigator:
          • Audrey FAVEYRIAL, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
18 months
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)
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2020

Primary Completion (Estimated)

September 3, 2023

Study Completion (Estimated)

March 3, 2025

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEBAPPAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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