Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)

Sponsor
Institut Bergonié (Other)
Overall Status
Unknown status
CT.gov ID
NCT03359759
Collaborator
Région Nouvelle Aquitaine (Other)
15
1
20
0.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conected objects

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Feb 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Quality of life of the patients [3 months]

    FACT-B questionnary

  2. Quality of life of the patients [6 months]

    FACT-B questionnary

  3. Quality of life of the patients [9 months]

    FACT-B questionnary

  4. Quality of life of the patients [12 months]

    FACT-B questionnary

  5. Quality of life of the patients [15 months]

    FACT-B questionnary

  6. Quality of life of the patients [18 months]

    FACT-B questionnary

  7. Quality of life of the patients [21 months]

    FACT-B questionnary

  8. Quality of life of the patients [24 months]

    FACT-B questionnary

Secondary Outcome Measures

  1. How patients feel about the study [3 months]

    General questionnary for satisfaction

  2. How patients feel about the study [6 months]

    General questionnary for satisfaction

  3. How patients feel about the study [9 months]

    General questionnary for satisfaction

  4. How patients feel about the study [12 months]

    General questionnary for satisfaction

  5. How patients feel about the study [15 months]

    General questionnary for satisfaction

  6. How patients feel about the study [18 months]

    General questionnary for satisfaction

  7. How patients feel about the study [21 months]

    General questionnary for satisfaction

  8. How patients feel about the study [24 months]

    General questionnary for satisfaction

  9. Number of consultation via telemedicine [through study completion, an average of 24 months]

    CRF done for each consultation

  10. Quality of sound and image quality [through study completion, an average of 24 months]

    CRF done for each consultation

  11. Medical actions after telemedicine [through study completion, an average of 24 months]

    CRF done for each consultation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Bergonie Bordeaux France 33076

Sponsors and Collaborators

  • Institut Bergonié
  • Région Nouvelle Aquitaine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT03359759
Other Study ID Numbers:
  • IB2016-eDOMSANTE
First Posted:
Dec 2, 2017
Last Update Posted:
Dec 2, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Bergonié

Study Results

No Results Posted as of Dec 2, 2017