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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03359759
Other study ID # IB2016-eDOMSANTE
Secondary ID
Status Recruiting
Phase N/A
First received November 27, 2017
Last updated November 30, 2017
Start date June 2016
Est. completion date February 2018

Study information

Verified date November 2017
Source Institut Bergonié
Contact Nathalie QUENEL-TUEUX, MD
Phone +33 5 56 33 32 58
Email n.quenel-tueux@bordeaux.unicancer.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational study about patients treated for a metastasis breast cancer who live far from their comprehensive cancer center and followed by telemedicine, connected wtaches and patient-reported symptom monitoring.


Description:

Every week, each patient report her symptoms and answer ten questions on the i-PAD. The connected watch reports the performance status (activtiy and time spent in bed or sitting), and the falls.

If nurses or doctors detect any problem, they ask the patient for a telemedicine to try to help her. During the same time, nurses or doctors send a message on a secure plateform to the local team (nurse, General Practitioner, and pharmacists) and they reserve a place for an hospitalization if necessary.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date February 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women more than 18 years old

- Treated for an advanced metastasis breast cancer

- Who live far from their comprehensive cancer center in the Landes department

Exclusion Criteria:

- Women who are not able to understand the study because of psychiatric disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conected objects
Every week, each patient report her symptoms and answer ten questions on the i-PAD. The connected watch reports the performance status (activtiy and time spent in bed or sitting), and the falls. If nurses or doctors detect any problem, they ask the patient for a telemedicine to try to help her. During the same time, nurses or doctors send a message on a secure plateform to the local team (nurse, General Practitioner, and pharmacists) and they reserve a place for an hospitalization if necessary.

Locations

Country Name City State
France Institut Bergonie Bordeaux

Sponsors (2)

Lead Sponsor Collaborator
Institut Bergonié Région Nouvelle Aquitaine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life of the patients FACT-B questionnary 3 months
Primary Quality of life of the patients FACT-B questionnary 6 months
Primary Quality of life of the patients FACT-B questionnary 9 months
Primary Quality of life of the patients FACT-B questionnary 12 months
Primary Quality of life of the patients FACT-B questionnary 15 months
Primary Quality of life of the patients FACT-B questionnary 18 months
Primary Quality of life of the patients FACT-B questionnary 21 months
Primary Quality of life of the patients FACT-B questionnary 24 months
Secondary How patients feel about the study General questionnary for satisfaction 3 months
Secondary How patients feel about the study General questionnary for satisfaction 6 months
Secondary How patients feel about the study General questionnary for satisfaction 9 months
Secondary How patients feel about the study General questionnary for satisfaction 12 months
Secondary How patients feel about the study General questionnary for satisfaction 15 months
Secondary How patients feel about the study General questionnary for satisfaction 18 months
Secondary How patients feel about the study General questionnary for satisfaction 21 months
Secondary How patients feel about the study General questionnary for satisfaction 24 months
Secondary Number of consultation via telemedicine CRF done for each consultation through study completion, an average of 24 months
Secondary Quality of sound and image quality CRF done for each consultation through study completion, an average of 24 months
Secondary Medical actions after telemedicine CRF done for each consultation through study completion, an average of 24 months
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