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Trial record 1 of 1 for:    opticoach
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Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer (OPTICOACH)

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ClinicalTrials.gov Identifier: NCT04469205
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Surgery Other: Coaching sessions Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : October 5, 2023
Estimated Study Completion Date : April 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of the return to work [ Time Frame: 6 and 12 months ]

    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


  2. Sustainability of the return to work [ Time Frame: 6 and 12 months ]
    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

  3. Impact of the return to work / work stoppage on the quality of life [ Time Frame: 6 and 12 months ]
    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

  4. The production losses related to presenteeism during maintenance or return to work [ Time Frame: 6 and 12 months ]
    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)

  5. The production losses related to presenteeism during maintenance or return to work [ Time Frame: 6 and 12 months ]
    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. The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality) [ Time Frame: 12 months ]

    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


  7. The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality) [ Time Frame: 6 and 12 months ]

    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


  8. The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality) [ Time Frame: 6 and 12 months ]

    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


  9. The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality) [ Time Frame: 6 and 12 months ]

    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


  10. The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality) [ Time Frame: 6 and 12 months ]

    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


  11. The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality) [ Time Frame: 6 and 12 months ]
    These determinants will also be evaluated through the collection of socio-demographic data, cancer characteristics and treatments administered.

  12. The medico-economic impact of returning to work [ Time Frame: 12 months ]
    Evaluation of the medico-economic impact of return to work by comparing the costs of care in the two groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469205


Contacts
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Contact: Enora LAAS-FARON, MD +33 1 56 24 62 36 enora.laas@curie.fr
Contact: Anne-Sophie PLISSONNIER +33 1 47 11 23 78 anne-sophie.plissonnier@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, France, 75005
Contact: Enora LAAS-FARON, MD         
Principal Investigator: Enora LAAS-FARON, MD         
Institut Curie Recruiting
Saint-Cloud, France, 92210
Contact: Claire BONNEAU, MD       claire.bonneau@curie.fr   
Principal Investigator: Claire BONNEAU, MD         
Sponsors and Collaborators
Institut Curie
More Information
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04469205    
Other Study ID Numbers: IC 2017-06
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases