Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work

Study Overview
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Brief Summary
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The diagnosis of breast cancer and the treatments implemented have a significant impact on the professional situation. Maintaining employment and/or reintegration into working life are therefore major issues for cancer patients. This trial proposes to study the feasibility of a support/coaching program for a return to work in patients after breast cancer.

Detailed Description
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This study involves patients with breast cancer at the end of their adjuvant treatment. The aim of this study is to evaluate the feasibility of a support program for an adapted return to work of these patients. This back-to-work support program including an individual interview to identify patient needs and expectations, 7 coaching workshops (every 3 weeks +/- 15 days) and a final individual assessment post workshops. The evolution of quality of life, psychological distress and perceptions concerning work will also be evaluated through assessments and questionnaires before (inclusion) and after the support program [1 month (+/- 7 days) and 6 months (+/- 1 month) after the final individual assessment]. The study also aims to estimate the recruitment rate in the study and to assess the satisfaction of this support program. Finally, the impact of this support program on the return to work will be described. This initial study will eventually lead to a larger research protocol on the effectiveness of the program, using a randomized controlled trial design.

Official Title
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Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Questionnaires
* Other: back to work coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patients cared at the Montpellier Cancer Institute (ICM) for non-metastatic breast cancer who have received adjuvant treatment (radiotherapy and/or chemotherapy) Patient who has completed adjuvant treatment, except for hormonotherapy Patient practicing a profession at the time of diagnosis, looking for a job or in professional retraining at the time of diagnosis Patient expressing spontaneously or on request of the oncologist physical or psychological difficulties in the professional field Patient wishing to be accompanied for an adapted return to her current job or for a return to a new more adapted job Patient who signed the informed consent after informed information by her clinician Exclusion Criteria: Metastatic breast cancer or any other cancer within the last 5 years Patient who haven't completed herr adjuvant treatment (chemotherapy and/or radiotherapy) Psychological condition requiring therapeutic support (objectified by the Mini International Neuropsychiatric Interview test (MINI) by identifying a Diagnostic and Statistical Manual (DSM)-IV Axis I psychiatric disorder (American Psychiatric Association, 1994) Sheehan et al., 1998) with the patient's refusal of adequate psychiatric treatment (medicated or not) at the time of inclusion in the study Severely impaired global cognitive functioning (objectified by an adjusted score of less than 20 on the Montreal Cognitive Assessment (MoCA) test) Physical inability to answer questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assessment of the feasibility and impact of a back-to-work support program<br>questionnaires, back to work coaching | Other: Questionnaires<br>* Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire<br>Other: back to work coaching<br>* Back-to-work support program including an individual interview to identify patient needs and expectations, 7 coaching workshops (every 3 weeks +/- 15 days) and a final individual assessment post workshops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient adherence of a coaching program for an adapted return to work | Assessment of the feasibility of a support program for an adapted return to work in patients with breast cancer, after their adjuvant treatment. Feasibility is defined by the proportion of patients who have adhered to the support program, with the patient attending at least 5 of the 7 proposed sessions. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the support program on the return to work | Description of the impact of the support program on return to work, defined as any return to work, regardless of the number of hours worked by the patient before diagnosis. The description will be made by the number of patients with a return to work (resumption of previous activity or new professional activity) and, if applicable, at what date. | At 1 month and at 6 months | 
| Estimation of recruitment rate in the study | Estimation of recruitment rate in the study by the proportion of patients agreeing to participate in the program among eligible patients | At inclusion | 
| Evolution of perceptions regarding work importance | The score on a visual analog work importance scale, ranging from 0 to 10 (10 indicating a high level of importance). | AT inclusion, at 1 month and 6 months | 
| Evolution of Work Ability | by the Work Ability Index, on a scale of 0 to 10 (10 indicating significant ability). | AT inclusion, at 1 month and 6 months | 
| Evolution of self-efficacy | The self-efficacy score , obtained on the Lagerveld et al. (2010) to 11 items (with a high score indicating a high degree of self-efficacy. | AT inclusion, at 1 month and 6 months | 
| Satisfaction of the support program Satisfaction of the support program | Assessment of the satisfaction of the support program by coaching. Assessment by program satisfaction score on a visual analog scale ranging from 1 to 10 (10 indicating high satisfaction) | At 1 month and at 6 months | 
| Quality of life (QoL) | By the QoL score obtained on the EORTC QLQ-C30 & EORTC QLQ-BR23 questionnaires | At inclusion, at 1 month and at 6 months | 
| Evolution of the psychological distress of patients | Description of the evolution of the psychological distress of patients. Measured by HADS scale (Hospital Anxiety and Depression Scale). The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. | At inclusion, at 1 month and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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return to work