Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00955-34 | Other Identifier | ID RCB number of competent autority in France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment of the feasibility and impact of a back-to-work support program | Other | questionnaires, back to work coaching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Pierre Bleuse | Contact | 04 67 61 31 02 | +33 | jean-pierre.bleuse@icm.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Estelle Guerdoux, Dr | Institut du Cancer de Montpellier - Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut du Cancer de Montpellier | Recruiting | Montpellier | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29776920 | Background | 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. | |
| 21933291 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| At 1 month and at 6 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 24000141 | 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. |
| 18349834 | 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. |
| 20164607 | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |