Skip to content

Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer

Randomized and Prospective Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04469205
Acronym
OPTICOACH
Enrollment
69
Registered
2020-07-13
Start date
2020-10-05
Completion date
2024-03-08
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Surgery

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.

Interventions

There are 3 sessions : the first session will last 1h30 and will be in consultation within the Institut Curie. The second session will last 1h30 and will be done remotely (by phone or by videoconference). The duration of the 3rd and last session will be adapted according to the needs of each patient and will last a maximum of 1 hour. It will also be done remotely (by phone or by videoconference).

Sponsors

Institut Curie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
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. 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

Design outcomes

Primary

MeasureTime frameDescription
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 study6 monthsThe 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

MeasureTime frameDescription
Sustainability of the return to work6 and 12 monthsEvaluation of the durability of the return to work at 6 and 12 months after inclusion by registration by the patients of the number of days off work and / or working time arrangement
Impact of the return to work / work stoppage on the quality of life6 and 12 monthsEvaluation of the impact of return to work / work stoppage on the quality of life estimated by QLQ-C30 questionnaire at baseline and at 6 and 12 months post-inclusion
Quality of the return to work6 and 12 monthsEvaluation of the quality of the return to work at 6 and 12 months after inclusion by questionnaire VOW / QFT (in case of return to work only). Evaluation scale : 1=never to 4=ever
The determinants of return to work (factors associated with a return to work successful: early, sustainable and quality)12 monthsDetermining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-BR23questionnaire. Evaluation scale : 0=not at all to 4=a lot
The medico-economic impact of returning to work12 monthsEvaluation of the medico-economic impact of return to work by comparing the costs of care in the two groups
The production losses related to presenteeism during maintenance or return to work6 and 12 monthsEvaluation of production losses related to presenteeism at the time of maintenance or return to work at 6 and 12 months post inclusion, by collecting the number of days worked during the study period (12 months)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026