NCT04469205TerminatedNot Applicable
Randomized and Prospective Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Institut Curie
- Enrollment
- 69
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
- •Invasive non-metastatic breast cancer, treated first by surgery
- •Age ≥ 18 and ≤ 60 years
- •Active woman at the time of diagnosis
- •Patient with internet access and email address
- •Patient affiliated with a social security scheme, speaking and reading French
- •Signature of informed consent
Exclusion Criteria
- •In situ breast cancer
- •History of breast cancer
- •Metastatic breast cancer
- •Inflammatory Breast Cancer
- •Woman with a life expectancy <6 months at the time of diagnosis (in relation to other serious chronic diseases)
- •Persons deprived of liberty or under guardianship
- •Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons
Outcomes
Primary Outcomes
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
Time Frame: 6 months
The rate of patients returning to work (part-time or full-time) for more than 2 weeks to 6 months of inclusion in the study in each group.
Secondary Outcomes
- Sustainability of the return to work(6 and 12 months)
- Quality of the return to work(6 and 12 months)
- Impact of the return to work / work stoppage on the quality of life(6 and 12 months)
- The medico-economic impact of returning to work(12 months)
- The production losses related to presenteeism during maintenance or return to work(6 and 12 months)
- The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)(6 and 12 months)
Investigators
Study Sites (3)
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