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

April 5, 2024 updated by: Institut Curie

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 and 12 months
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
6 and 12 months
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
6 and 12 months
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)
6 and 12 months
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 and 12 months
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
12 months
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
6 and 12 months
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
6 and 12 months
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
6 and 12 months
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
6 and 12 months
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.
6 and 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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