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Clinical Trials/NCT03359759
NCT03359759CompletedNot Applicable

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

Institut Bergonié1 site in 1 country15 target enrollmentStarted: January 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Quality of Life of the Patients at 12 Months

Study Overview

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 watches and patient-reported symptom monitoring.

Detailed Description

The effectiveness of remote follow-up of cancer patients through weekly medicalquestionnaires filled in on their smartphone has been reported in international studies. Thesestudies demonstrated an improvement in quality of life (QoL) and survival of several months. Thee-DomSanté study proposes the combined use of innovative technological tools for theimprovement of patient care

This study was carried out with patients followed-up for metastatic breast cancer who lived far from their treatment center. They were offered, in addition to their usual follow-up, weekly medical questionnaires on an interactive tablet and aconnected watch that registered their falls, bedtime and their general activity. All this data arrive on a secure portal. In the event of an alert, telemedicine is organized by remote consultation with exchange on a secure platform, in parallel, between the center's carers and the treating physician, nurse, pharmacist or the Territorial Support Unit. The evaluation criteria used include telemedicine and patients' quality of life questionnaires as well as their satisfaction with care.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Quality of Life of the Patients at 12 Months

Time Frame: 12 months

QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings. Total score range: 0-148 A higher score indicates better quality of life.

Quality of Life of the Patients at 6 Months

Time Frame: 6 months

QoL assessed using the score of the FACT-B questionnaire. The FACT-B (Functional Assessment of Cancer Therapy - Breast) is a quality of life questionnaire used primarily with breast cancer patients. It is a validated tool used in both clinical and research settings. Total score range: 0-148 A higher score indicates better quality of life.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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