Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study

Breast Cancer Clinical Trial

— VocRehab  

Official title:

Multidisciplinary Vocational Rehabilitation Intervention to Support the Return to Work of Breast Cancer Patients: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309265
• Other study ID #: 2022/0035986
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: May 2024

Study information

• Verified date: June 2023
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: Sara Paltrinieri, Msc OT
• Phone: 0039 3477825250
• Email: sara.paltrinieri[@]ausl.re.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Italy, 50% of new breast cancer (BC) diagnosis occur in female of working age. Although return to work (RTW) is strongly desired by BC patients, cancer survivors are more likely to be unemployed than healthy individuals. Moreover, work difficulties may hindrance this process. Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. To date, the feasibility of the multidisciplinary vocational rehabilitation interventions has not been verified for BC patients.

Description:

BC is a public health burden with increasing trends in Western countries. In Italy, 50% of the new BC diagnosis have occurred in female of working age. Even though the return to work (RTW) is strongly desired, cancer survivors are 1.4 times more likely to be unemployed than healthy individuals. Furthermore, work difficulties may occur during this process. To promote the RTW, multidisciplinary interventions have shown moderate quality evidence in cancer survivors.

Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. During the implementation of the pathway, BC patients were referred mainly by the physiotherapists of the Physical Medicine and Rehabilitation Unit (PMRU). As standard care, BC patients can participate to an educational group session held by the physiotherapists after surgery. During this session, work difficulties have emerged.

Thus, the investigators aim to verify the feasibility of the multidisciplinary vocational rehabilitation intervention for a sample of BC patients whit work difficulties who will participate to an educational group session held by the physiotherapists.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• breast cancer diagnosis (regardless of stage and treatment)

• breast cancer patients in working age

• breast cancer patient who will participate to an educational group session held by the physiotherapists of the PMRU

• breast cancer patients with work difficulties

Exclusion Criteria:

• Breast cancer patients with work issues that cannot be addressed by any of the interventions (e.g., patients who would like to change their job)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms

Intervention

Other:
• Multidisciplinary vocational rehabilitation intervention
Information aims to provide tailored information concerning the work law protection (this support is already provided for all patients, regardless the type of disease, and also for citizens); Occupational therapy aims to facilitate the reintegration in the previous workplace through the development of a rehabilitation intervention to overcome work difficulties in agreement with employee, employer and occupational physician, Social support aims to find new job opportunities (for those who have lost the employment due to the disease) through the giving of support in job search, curriculum preparation, skill analysis, professional retraining and education.

Locations

Country	Name	City	State
Italy	Azienda Unità Sanitaria Locale Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interception	rate of patients who has been proposed to participate to the feasibility study	12 months
Primary	acceptation	rate of patients (who has been proposed to participate to the feasibility study) who accept to participate	12 months
Primary	adherence	rate of patients who participate in the scheduled meeting and in the multidisciplinary intervention proposed; rate of patients who agree to receive the intervention at the workplace (for those eligible)	12 months
Primary	lost to follow-up	rate of patients who will not attend the scheduled meeting (drop-out rate set = 20%)	12 months
Primary	satisfaction rate	rate of patients who perceive the modules of the multidisciplinary intervention as supportive for their RTW or work continuation	12 months
Primary	RTW/work continuation	rate of patients who participate in the study and who will RTW or continued to work	12 months