Back to resultsProfessional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work (VISIBILITE)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
back to work coaching
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring return to work
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
Sites / Locations
- Institut du Cancer de MontpellierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Assessment of the feasibility and impact of a back-to-work support program
Arm Description
questionnaires, back to work coaching
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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).
Evolution of Work Ability
by the Work Ability Index, on a scale of 0 to 10 (10 indicating significant ability).
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.
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)
Quality of life (QoL)
By the QoL score obtained on the EORTC QLQ-C30 & EORTC QLQ-BR23 questionnaires
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.
Full Information
NCT ID
NCT05056350
First Posted
September 7, 2021
Last Updated
August 22, 2023
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT05056350
Brief Title
Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work
Acronym
VISIBILITE
Official Title
Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
August 22, 2023 (Anticipated)
Study Completion Date
August 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
return to work
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assessment of the feasibility and impact of a back-to-work support program
Arm Type
Other
Arm Description
questionnaires, back to work coaching
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire
Intervention Type
Other
Intervention Name(s)
back to work coaching
Intervention Description
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 Measure Information:
Title
Patient adherence of a coaching program for an adapted return to work
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Impact of the support program on the return to work
Description
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.
Time Frame
At 1 month and at 6 months
Title
Estimation of recruitment rate in the study
Description
Estimation of recruitment rate in the study by the proportion of patients agreeing to participate in the program among eligible patients
Time Frame
At inclusion
Title
Evolution of perceptions regarding work importance
Description
The score on a visual analog "work importance" scale, ranging from 0 to 10 (10 indicating a high level of importance).
Time Frame
AT inclusion, at 1 month and 6 months
Title
Evolution of Work Ability
Description
by the Work Ability Index, on a scale of 0 to 10 (10 indicating significant ability).
Time Frame
AT inclusion, at 1 month and 6 months
Title
Evolution of self-efficacy
Description
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.
Time Frame
AT inclusion, at 1 month and 6 months
Title
Satisfaction of the support program Satisfaction of the support program
Description
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)
Time Frame
At 1 month and at 6 months
Title
Quality of life (QoL)
Description
By the QoL score obtained on the EORTC QLQ-C30 & EORTC QLQ-BR23 questionnaires
Time Frame
At inclusion, at 1 month and at 6 months
Title
Evolution of the psychological distress of patients
Description
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.
Time Frame
At inclusion, at 1 month and at 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre Bleuse
Phone
04 67 61 31 02
Ext
+33
Email
jean-pierre.bleuse@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Estelle Guerdoux, Dr
Organizational Affiliation
Institut du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Guerdoux, Dr
Phone
04 67 61 24 68
Ext
+33
Email
estelle.guerdoux-ninot@icm.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29776920
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.
Results Reference
background
PubMed Identifier
21933291
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.
Results Reference
background
PubMed Identifier
24000141
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.
Results Reference
background
PubMed Identifier
18349834
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.
Results Reference
background
PubMed Identifier
20164607
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.
Results Reference
background
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Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work
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