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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04469205
• Other study ID #: IC 2017-06
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: March 8, 2024

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: March 8, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

Intervention

Other:
• Coaching sessions
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).

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Institut Curie	Saint-Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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	6 and 12 months
Secondary	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	6 and 12 months
Secondary	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	6 and 12 months
Secondary	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)	6 and 12 months
Secondary	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	6 and 12 months
Secondary	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	12 months
Secondary	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	6 and 12 months
Secondary	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	6 and 12 months
Secondary	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	6 and 12 months
Secondary	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	6 and 12 months
Secondary	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.	6 and 12 months
Secondary	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	12 months