NCT04554927

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

September 3, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 22, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

September 14, 2020

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Quality of life with self questionnaires

    18 months

  • Quality of life with self questionnaires

    18 months

Study Arms (2)

WEB-application

EXPERIMENTAL
Other: WEB-Application

Standard accompaniment

ACTIVE COMPARATOR
Other: Standard accompaniment

Interventions

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).

WEB-application

Personalized schedule of medical follow-up given to the patient

Standard accompaniment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François baclesse

Caen, 14000, France

RECRUITING

Related Publications (1)

  • Gernier F, Grellard JM, Dupont C, Castel H, Fernette M, Lahaye F, Charles RM, Leroux T, Ory C, Faveyrial A, Morel A, Emile G, Levy C, Segura C, Allouache D, Johnson A, Geffrelot J, Gunzer K, Lelaidier A, Girault G, Dubot-Poitelon C, San C, Lequesne J, Clarisse B. Impact of web application support versus standard management on adherence with adjuvant hormone therapy in patients treated for breast cancer: the WEBAPPAC study. BMC Cancer. 2023 Aug 9;23(1):736. doi: 10.1186/s12885-023-11242-1.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

September 3, 2020

Primary Completion

October 11, 2024

Study Completion

December 31, 2025

Last Updated

September 22, 2025

Record last verified: 2025-08

Locations