Institut du Cancer de Montpellier
Montpellier, 34298, France
Location status: Recruiting
NCT Number: NCT05056350
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Montpellier, 34298, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire
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
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.
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.
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
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).
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).
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.
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)
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
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.
Contact information is provided by the study sponsor or research team.
Institut du Cancer de Montpellier - Val d'Aurelle
Other
Acronym: VISIBILITE
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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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