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

NCT ID: NCT04469205

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2024-03-08

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.

Conditions

Breast Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Coaching sessions

Intervention Type: OTHER

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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Curie

Paris, , France

Institut Curie

Saint-Cloud, , France

Countries

France

Other Identifiers

IC 2017-06

Identifier Type: -

Identifier Source: org_study_id