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

NCT05056350 | Recruiting

• 2 other identifiers: PROICM 2020-07 VIS2020-A00955-34
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

return to work

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Impact of the support program on the return to work

  At 1 month and at 6 months

• Estimation of recruitment rate in the study

  At inclusion

• Evolution of perceptions regarding work importance

  AT inclusion, at 1 month and 6 months

• Evolution of Work Ability

  AT inclusion, at 1 month and 6 months

• Evolution of self-efficacy

  AT inclusion, at 1 month and 6 months

Study Arms (1)

Assessment of the feasibility and impact of a back-to-work support program

OTHER

questionnaires, back to work coaching

Other: Questionnaires; Other: back to work coaching

Interventions

Questionnaires OTHER

Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire

Assessment of the feasibility and impact of a back-to-work support program

back to work coaching OTHER

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

Assessment of the feasibility and impact of a back-to-work support program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Metastatic breast cancer or any other cancer within the last 5 years
• Patient who haven't completed herr adjuvant treatment (chemotherapy and/or radiotherapy)
• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut du Cancer de Montpellier

Montpellier, 34298, France

RECRUITING

Related 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.

  PMID: 29776920 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Estelle Guerdoux, Dr

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Central Study Contacts

Jean-Pierre Bleuse

CONTACT

04 67 61 31 02; jean-pierre.bleuse@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 24, 2021
• Study Start: September 13, 2021
• Primary Completion: January 31, 2024
• Study Completion (Estimated): August 22, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)