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

NCT04469205 | Terminated

• 1 other identifier: IC 2017-06
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (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

  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 Outcomes (12)

• Quality of the return to work

  6 and 12 months

• Sustainability of the return to work

  6 and 12 months

• Impact of the return to work / work stoppage on the quality of life

  6 and 12 months

• The production losses related to presenteeism during maintenance or return to work

  6 and 12 months

• The production losses related to presenteeism during maintenance or return to work

  6 and 12 months

Study Arms (2)

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.

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.

Interventions

Coaching sessions 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).

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (2)

Institut Curie

Paris, 75005, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: July 13, 2020
• Study Start: October 5, 2020
• Primary Completion: June 15, 2023
• Study Completion: March 8, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• 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).

Locations

FR (2)