Clinical trial NCT05056350: Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work
Official title: Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: return to work
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

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

Primary outcomes:
measure: Patient adherence of a coaching program for an adapted return to work
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Impact of the support program on the return to work
timeFrame: At 1 month and at 6 months
measure: Estimation of recruitment rate in the study
timeFrame: At inclusion
measure: Evolution of perceptions regarding work importance
timeFrame: AT inclusion, at 1 month and 6 months
measure: Evolution of Work Ability
timeFrame: AT inclusion, at 1 month and 6 months
measure: Evolution of self-efficacy
timeFrame: AT inclusion, at 1 month and 6 months
measure: Satisfaction of the support program Satisfaction of the support program
timeFrame: At 1 month and at 6 months
measure: Quality of life (QoL)
timeFrame: At inclusion, at 1 month and at 6 months
measure: Evolution of the psychological distress of patients
timeFrame: At inclusion, at 1 month and at 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Estelle Guerdoux, Dr
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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.