E-monitoring of Patients Under Adjuvant Hormonotherapy fo... | NCT04228432

Studies
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.

NCT04228432

Sponsor

Institut Claudius Regaud

Status

Completed

Last Update Posted

Jul 27, 2021Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Dedicated and coordinated monitoring

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2020Actual

Primary Completion Date

Jul 21, 2021Actual

Completion Date

Jul 21, 2021Actual

First Submitted Date

Jan 10, 2020

First Submission Date that Met QC Criteria

Jan 13, 2020

First Posted Date

Jan 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2021

Last Update Posted Date

Jul 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .

45 patients will be included.

Patients will be followed during 6 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with breast cancer treated by adjuvant hormonotherapy	Experimental		Other: Dedicated and coordinated monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dedicated and coordinated monitoring	Other	Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of patients who do not fail the E-Monitoring protocol		6 months per patient

Secondary Outcomes

Measure	Description	Time Frame
Number of medical consultations required over 6 months		6 months per patient
Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire		6 months per patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
Patient equipped with a computer or tablet computer and an internet connection at home
Age > 18 years old
Patient affiliated to the french social security system
Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
Women of childbearing age should have effective contraception under hormonotherapy

Exclusion Criteria:

Patient with breast cancer who does not require adjuvant hormonotherapy
Patient with metastatic breast cancer
Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
Patient protected by law.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided