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

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

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 Overview

• Status: Terminated
• Conditions: Breast Cancer; Surgery
• Intervention / Treatment: Other: Coaching sessions

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enora LAAS-FARON, MD; Phone Number: +33 1 56 24 62 36; Email: enora.laas@curie.fr
• Study Contact Backup: Name: Anne-Sophie PLISSONNIER; Phone Number: +33 1 47 11 23 78; Email: anne-sophie.plissonnier@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie
  • Saint-Cloud, France, 92210
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	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).
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IC 2017-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No