Breast CancerOPTICOACHNCT04469205
Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer
A study testing Coaching sessions in people with Breast Cancer and Surgery, run by Institut Curie at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- Coaching sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Oct 2020to 8 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Breast Cancer, Surgery
- Being tested
- Coaching sessions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching sessionsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Coaching sessions |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start5 Oct 2020
- Primary completion15 Jun 2023
- Study completion8 Mar 2024
Why it stopped: insufficient recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469205
- Sponsor's protocol ID
- IC 2017-06
- Acronym
- OPTICOACH
- Status last verified
- Jan 2024
- First submitted
- 8 Jun 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04469205
- Acronym / sponsor ID
- OPTICOACH / IC 2017-06
- Conditions
- Breast Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Coaching sessionsintervention 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching sessionsThere 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). | Other | Intervention Group |
Primary outcome
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.
12 secondary outcomes
Quality of the return to work
Time frame: 6 and 12 months
Sustainability of the return to work
Time frame: 6 and 12 months
Impact of the return to work / work stoppage on the quality of life
Time frame: 6 and 12 months
The production losses related to presenteeism during maintenance or return to work
Time frame: 6 and 12 months
The production losses related to presenteeism during maintenance or return to work
Time frame: 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
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Time frame: 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
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Time frame: 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
The determinants of return to work (factors associated with a return to work "successful": early, sustainable and quality)
Time frame: 6 and 12 months
The medico-economic impact of returning to work
Time frame: 12 months
Results and safety
The study was stopped early (reason given: insufficient recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching sessions in people with Breast Cancer and Surgery, run by Institut Curie at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.