Clinical trial NCT04469205: Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer
Official title: Randomized and Prospective Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Surgery
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluate the impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study for breast cancer in professionnally active patients.


Eligibility criteria: Inclusion Criteria:

Any patient active at the time of the diagnosis of breast cancer, treated consecutively at the Institut Curie during the study period, and whose first treatment will be surgery, will be offered participation in the study.

1. Invasive non-metastatic breast cancer, treated first by surgery
2. Age ≥ 18 and ≤ 60 years
3. Active woman at the time of diagnosis
4. Patient with internet access and email address
5. Patient affiliated with a social security scheme, speaking and reading French
6. Signature of informed consent

Exclusion Criteria:

1. In situ breast cancer
2. History of breast cancer
3. Metastatic breast cancer
4. Inflammatory Breast Cancer
5. Woman with a life expectancy \<6 months at the time of diagnosis (in relation to other serious chronic diseases)
6. Persons deprived of liberty or under guardianship
7. Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons

Primary outcomes:
measure: Impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study
timeFrame: 6 months
Secondary outcomes:
measure: Quality of the return to work
timeFrame: 6 and 12 months
measure: Sustainability of the return to work
timeFrame: 6 and 12 months
measure: Impact of the return to work / work stoppage on the quality of life
timeFrame: 6 and 12 months
measure: The production losses related to presenteeism during maintenance or return to work
timeFrame: 6 and 12 months
measure: The production losses related to presenteeism during maintenance or return to work
timeFrame: 6 and 12 months
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
timeFrame: 12 months
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
timeFrame: 6 and 12 months
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
timeFrame: 6 and 12 months
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
timeFrame: 6 and 12 months
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
timeFrame: 6 and 12 months
measure: The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
timeFrame: 6 and 12 months
measure: The medico-economic impact of returning to work
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Saint-Cloud
country: France
facility: Institut Curie
Study officials:
References: