Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer (WEBAPPAC)
Primary Purpose
Web-application, Breast Cancer, Hormono Therapy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
WEB-Application
Standard accompaniment
Sponsored by
About this trial
This is an interventional other trial for Web-application
Eligibility 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
Sites / Locations
- Centre François baclesseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WEB-application
Standard accompaniment
Arm Description
Outcomes
Primary Outcome Measures
Observance of hormontherapy
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
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
uality of life scores according (EORTC QLQ-BR23 self-questionnaires ; minimum not at all to maximum Lot; 23 questions)
Full Information
NCT ID
NCT04554927
First Posted
September 14, 2020
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT04554927
Brief Title
Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
September 3, 2023 (Anticipated)
Study Completion Date
March 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Web-application, Breast Cancer, Hormono Therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WEB-application
Arm Type
Experimental
Arm Title
Standard accompaniment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
WEB-Application
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Standard accompaniment
Intervention Description
Personalized schedule of medical follow-up given to the patient
Primary Outcome Measure Information:
Title
Observance of hormontherapy
Description
Evaluate the benefit of a web-based application on hormone therapy compliance (Morisky questionnary; answer Yes or No; 8 questions)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Quality of life with self questionnaires
Description
Quality of life scores according (EORTC QLQ-C30 self-questionnaires ; minimum not at all to maximum Lot; 30 questions)
Time Frame
18 months
Title
Quality of life with self questionnaires
Description
uality of life scores according (EORTC QLQ-BR23 self-questionnaires ; minimum not at all to maximum Lot; 23 questions)
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre François baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GERNIER, Study nurse
Phone
+ 33 2 31 45 50 50
Email
f.gernier@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel GRELLARD, project manager
Phone
+ 33 2 31 45 50 50
Email
jm.grellard@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
François GERNIER, Study nurse
First Name & Middle Initial & Last Name & Degree
Gaelle ANNE, Study nurse
First Name & Middle Initial & Last Name & Degree
Charlotte CEINTRE, Study nurse
First Name & Middle Initial & Last Name & Degree
Rose-Marie CHARLES, Study nurse
First Name & Middle Initial & Last Name & Degree
Audrey FAVEYRIAL, MD
First Name & Middle Initial & Last Name & Degree
Christelle LEVY, MD
First Name & Middle Initial & Last Name & Degree
Emile GEORGE, MD
First Name & Middle Initial & Last Name & Degree
Djelila ALLOUACHE, MD
First Name & Middle Initial & Last Name & Degree
Julien GEFFRELOT, MD
First Name & Middle Initial & Last Name & Degree
Carine SEGURA, MD
First Name & Middle Initial & Last Name & Degree
Katharina GUNZER, MD
First Name & Middle Initial & Last Name & Degree
Ioana HRAB, MD
First Name & Middle Initial & Last Name & Degree
Alison JOHNSON, MD
First Name & Middle Initial & Last Name & Degree
Adeline MOREL, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer
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