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

Breast Cancer Clinical Trial

— VISIBILITE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056350
• Other study ID #: PROICM 2020-07 VIS
• Secondary ID: 2020-A00955-34
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: August 22, 2023

Study information

• Verified date: August 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Jean-Pierre Bleuse
• Phone: 04 67 61 31 02
• Email: jean-pierre.bleuse[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Questionnaires
Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire
• back to work coaching
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

Locations

Country	Name	City	State
France	Institut du Cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (5)

Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Hequet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276. — View Citation

Banning M. Employment and breast cancer: a meta-ethnography. Eur J Cancer Care (Engl). 2011 Nov;20(6):708-19. doi: 10.1111/j.1365-2354.2011.01291.x. Epub 2011 Sep 20. — View Citation

Barnes AJ, Robert N, Bradley CJ. Job attributes, job satisfaction and the return to health after breast cancer diagnosis and treatment. Psychooncology. 2014 Feb;23(2):158-64. doi: 10.1002/pon.3385. Epub 2013 Sep 3. — View Citation

de Boer AG, Verbeek JH, Spelten ER, Uitterhoeve AL, Ansink AC, de Reijke TM, Kammeijer M, Sprangers MA, van Dijk FJ. Work ability and return-to-work in cancer patients. Br J Cancer. 2008 Apr 22;98(8):1342-7. doi: 10.1038/sj.bjc.6604302. Epub 2008 Mar 18. — View Citation

Ekbladh E, Thorell LH, Haglund L. Perceptions of the work environment among people with experience of long term sick leave. Work. 2010;35(2):125-36. doi: 10.3233/WOR-2010-0964. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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