Trial Outcomes & Findings for Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté) (NCT NCT03359759)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

12 months

Results posted on

2025-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Advanced Disease Patients treated for an advanced metastasis breast cancer
Overall Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Advanced Disease Patients treated for an advanced metastasis breast cancer
Overall Study Death	3
Overall Study Lost to Follow-up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Advanced Disease n=15 Participants Patients treated for an advanced metastasis breast cancer
Age, Continuous	65 years n=4 Participants
Sex: Female, Male Female	15 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=4 Participants
Region of Enrollment France	15 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Patients alive, not lost to follow-up, and with a completed questionnaire

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.

Outcome measures

Outcome measures
Measure	Patients With Advanced Disease n=8 Participants Patients treated for an advanced metastasis breast cancer
Quality of Life of the Patients at 12 Months	59 score on a scale Interval 32.0 to 84.0

PRIMARY outcome

Timeframe: 6 months

Population: Patients alive, not lost to follow-up, and with a completed questionnaire

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.

Outcome measures

Outcome measures
Measure	Patients With Advanced Disease n=11 Participants Patients treated for an advanced metastasis breast cancer
Quality of Life of the Patients at 6 Months	58 score on a scale Interval 33.0 to 77.0

Adverse Events

Patients With Advanced Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simone Mathoulin-Pélissier, Director of Clinical Trials

Institut Bergonié

Phone: +33556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place