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

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Recruiting

CT.gov ID

NCT04554927

Collaborator

(none)

438

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 3, 2020

Anticipated Primary Completion Date :

Sep 3, 2022

Anticipated Study Completion Date :

Mar 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

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

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

Quality of life with self questionnaires [18 months]
Quality of life scores according (EORTC QLQ-C30 self-questionnaires ; minimum not at all to maximum Lot; 30 questions)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Centre François baclesse	Caen		France	14000

Sponsors and Collaborators

Centre Francois Baclesse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Francois Baclesse

ClinicalTrials.gov Identifier:

NCT04554927

Other Study ID Numbers:

WEBAPPAC

First Posted:

Sep 18, 2020

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Feb 17, 2022