Back to resultsStudy to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer (OPTICOACH)
Primary Purpose
Breast Cancer, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coaching sessions
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer
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.
- 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
Sites / Locations
- Institut CurieRecruiting
- Institut CurieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
intervention group that will receive return-to-work coaching sessions. The intervention consists of 3 individual coaching sessions with a certified professional coach. This personalized accompaniment will complete the standard accompaniment offered to all patients.
control group who will receive the current care which consists of a psychosocial care. This care consists in offering the patient regular information meetings organized with social workers of the Health Insurance, to consult a psychologist and to access patients' homes at the frequency of their choice and according to their need.
Outcomes
Primary Outcome Measures
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
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 Outcome Measures
Quality of the return to work
Evaluation 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
Sustainability of the return to work
Evaluation 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 life
Evaluation 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
The production losses related to presenteeism during maintenance or return to work
Evaluation 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)
The production losses related to presenteeism during maintenance or return to work
Evaluation of the loss of productivity during a professional activity : in case of return to work, the "Work limitation questionnaire" will be completed at 6 and 12 months after inclusion
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Determining 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 determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-FA12 questionnaire.
Evaluation scale : 0=not at all to 4=a lot
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Determining the determinants of return to work at 6 and 12 months post inclusion using the HADS questionnaire.
Anxiety scale : 3=most of the time to 0=never Depression scale : 3=never to 0= most of the time
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Determining the determinants of return to work at 6 and 12 months post inclusion using the SSQ6 questionnaire.
Evaluation scale : 1=really dissatisfied to 6 =really satisfied
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Determining the determinants of return to work at 6 and 12 months post inclusion using the Brief Cope questionnaire.
Evaluation scale : 0=not at all to 4=absolutely
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
These determinants will also be evaluated through the collection of socio-demographic data, cancer characteristics and treatments administered.
The medico-economic impact of returning to work
Evaluation of the medico-economic impact of return to work by comparing the costs of care in the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04469205
Brief Title
Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer
Acronym
OPTICOACH
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
April 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
intervention group that will receive return-to-work coaching sessions. The intervention consists of 3 individual coaching sessions with a certified professional coach. This personalized accompaniment will complete the standard accompaniment offered to all patients.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
control group who will receive the current care which consists of a psychosocial care.
This care consists in offering the patient regular information meetings organized with social workers of the Health Insurance, to consult a psychologist and to access patients' homes at the frequency of their choice and according to their need.
Intervention Type
Other
Intervention Name(s)
Coaching sessions
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of the return to work
Description
Evaluation 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
Time Frame
6 and 12 months
Title
Sustainability of the return to work
Description
Evaluation 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
Time Frame
6 and 12 months
Title
Impact of the return to work / work stoppage on the quality of life
Description
Evaluation 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
Time Frame
6 and 12 months
Title
The production losses related to presenteeism during maintenance or return to work
Description
Evaluation 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)
Time Frame
6 and 12 months
Title
The production losses related to presenteeism during maintenance or return to work
Description
Evaluation of the loss of productivity during a professional activity : in case of return to work, the "Work limitation questionnaire" will be completed at 6 and 12 months after inclusion
Time Frame
6 and 12 months
Title
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Description
Determining 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
Time Frame
12 months
Title
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Description
Determining the determinants of return to work at 6 and 12 months post inclusion using the QLQ-FA12 questionnaire.
Evaluation scale : 0=not at all to 4=a lot
Time Frame
6 and 12 months
Title
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Description
Determining the determinants of return to work at 6 and 12 months post inclusion using the HADS questionnaire.
Anxiety scale : 3=most of the time to 0=never Depression scale : 3=never to 0= most of the time
Time Frame
6 and 12 months
Title
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Description
Determining the determinants of return to work at 6 and 12 months post inclusion using the SSQ6 questionnaire.
Evaluation scale : 1=really dissatisfied to 6 =really satisfied
Time Frame
6 and 12 months
Title
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Description
Determining the determinants of return to work at 6 and 12 months post inclusion using the Brief Cope questionnaire.
Evaluation scale : 0=not at all to 4=absolutely
Time Frame
6 and 12 months
Title
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Description
These determinants will also be evaluated through the collection of socio-demographic data, cancer characteristics and treatments administered.
Time Frame
6 and 12 months
Title
The medico-economic impact of returning to work
Description
Evaluation of the medico-economic impact of return to work by comparing the costs of care in the two groups
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enora LAAS-FARON, MD
Phone
+33 1 56 24 62 36
Email
enora.laas@curie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie PLISSONNIER
Phone
+33 1 47 11 23 78
Email
anne-sophie.plissonnier@curie.fr
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enora LAAS-FARON, MD
First Name & Middle Initial & Last Name & Degree
Enora LAAS-FARON, MD
Facility Name
Institut Curie
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BONNEAU, MD
Email
claire.bonneau@curie.fr
First Name & Middle Initial & Last Name & Degree
Claire BONNEAU, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer
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