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NCT Number: NCT05056350

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut du Cancer de Montpellier

Montpellier, 34298, France

Location status: Recruiting

Location contact

Estelle Guerdoux, Dr

CONTACT

[email protected]

04 67 61 24 68 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

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

Primary outcomes

  1. Patient adherence of a coaching program for an adapted return to work

    Time frame: through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Impact of the support program on the return to work

    Time frame: At 1 month and at 6 months

    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.

  2. Estimation of recruitment rate in the study

    Time frame: At inclusion

    Estimation of recruitment rate in the study by the proportion of patients agreeing to participate in the program among eligible patients

  3. Evolution of perceptions regarding work importance

    Time frame: AT inclusion, at 1 month and 6 months

    The score on a visual analog "work importance" scale, ranging from 0 to 10 (10 indicating a high level of importance).

  4. Evolution of Work Ability

    Time frame: AT inclusion, at 1 month and 6 months

    by the Work Ability Index, on a scale of 0 to 10 (10 indicating significant ability).

  5. Evolution of self-efficacy

    Time frame: AT inclusion, at 1 month and 6 months

    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.

  6. Satisfaction of the support program Satisfaction of the support program

    Time frame: At 1 month and at 6 months

    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)

  7. Quality of life (QoL)

    Time frame: At inclusion, at 1 month and at 6 months

    By the QoL score obtained on the EORTC QLQ-C30 & EORTC QLQ-BR23 questionnaires

  8. Evolution of the psychological distress of patients

    Time frame: At inclusion, at 1 month and at 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Pierre Bleuse

CONTACT

[email protected]

04 67 61 31 02 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: VISIBILITE

Important dates

Study start
2021
Primary completion
2024
Study completion
2027
First posted
Sep 24, 2021
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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