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

Overview

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

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.

Interventions

• Other Questionnaires
  Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire
• Other 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

Primary outcome measures

• Patient adherence of a coaching program for an adapted return to work [Time frame: through study completion, an average of 1 year]

Secondary outcome measures (8)

• Impact of the support program on the return to work [Time frame: At 1 month and at 6 months]
• Estimation of recruitment rate in the study [Time frame: At inclusion]
• Evolution of perceptions regarding work importance [Time frame: AT inclusion, at 1 month and 6 months]
• Evolution of Work Ability [Time frame: AT inclusion, at 1 month and 6 months]
• Evolution of self-efficacy [Time frame: AT inclusion, at 1 month and 6 months]
• Satisfaction of the support program Satisfaction of the support program [Time frame: At 1 month and at 6 months]
• Quality of life (QoL) [Time frame: At inclusion, at 1 month and at 6 months]
• Evolution of the psychological distress of patients [Time frame: At inclusion, at 1 month and at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Institut du Cancer de Montpellier — Montpellier

Publications

• 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. PMID 29776920
• 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. PMID 21933291
• 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. PMID 24000141
• 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. PMID 18349834
• 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. PMID 20164607

Identifiers

NCT: NCT05056350 · PROICM 2020-07 VIS · 2020-A00955-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗