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

Primary Purpose

Breast Cancer, Breast Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Multidisciplinary vocational rehabilitation intervention
Sponsored by
Azienda Unità Sanitaria Locale Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Cancer Survivors, Return to work, Vocational Rehabilitation, Occupational Therapy

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Azienda Unità Sanitaria Locale Reggio EmiliaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Breast cancer patients with work difficulties

Arm Description

Breast cancer patients with work difficulties can receive any of the three types of support, or a combination of these: information, occupational therapy and social support, in order to overcome barriers and return to work/continue to work

Outcomes

Primary Outcome Measures

interception
rate of patients who has been proposed to participate to the feasibility study
acceptation
rate of patients (who has been proposed to participate to the feasibility study) who accept to participate
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)
lost to follow-up
rate of patients who will not attend the scheduled meeting (drop-out rate set ≤ 20%)
satisfaction rate
rate of patients who perceive the modules of the multidisciplinary intervention as supportive for their RTW or work continuation
RTW/work continuation
rate of patients who participate in the study and who will RTW or continued to work

Secondary Outcome Measures

Full Information

First Posted
March 25, 2022
Last Updated
June 27, 2023
Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT05309265
Brief Title
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study
Acronym
VocRehab
Official Title
Multidisciplinary Vocational Rehabilitation Intervention to Support the Return to Work of Breast Cancer Patients: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasm
Keywords
Cancer Survivors, Return to work, Vocational Rehabilitation, Occupational Therapy

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
Breast cancer patients with work difficulties
Arm Type
Other
Arm Description
Breast cancer patients with work difficulties can receive any of the three types of support, or a combination of these: information, occupational therapy and social support, in order to overcome barriers and return to work/continue to work
Intervention Type
Other
Intervention Name(s)
Multidisciplinary vocational rehabilitation intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
interception
Description
rate of patients who has been proposed to participate to the feasibility study
Time Frame
12 months
Title
acceptation
Description
rate of patients (who has been proposed to participate to the feasibility study) who accept to participate
Time Frame
12 months
Title
adherence
Description
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)
Time Frame
12 months
Title
lost to follow-up
Description
rate of patients who will not attend the scheduled meeting (drop-out rate set ≤ 20%)
Time Frame
12 months
Title
satisfaction rate
Description
rate of patients who perceive the modules of the multidisciplinary intervention as supportive for their RTW or work continuation
Time Frame
12 months
Title
RTW/work continuation
Description
rate of patients who participate in the study and who will RTW or continued to work
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Paltrinieri, Msc OT
Phone
0039 3477825250
Email
sara.paltrinieri@ausl.re.it
First Name & Middle Initial & Last Name or Official Title & Degree
Stefania Costi, PhD
Phone
0039 0522 522441
Email
stefania.costi@unimore.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Paltrinieri, Msc OT
Organizational Affiliation
Azienda Unità Sanitaria Locale Reggio Emilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Unità Sanitaria Locale Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Paltrinieri, Msc OT
Phone
00390522522416
Email
sara.paltrinieri@ausl.re.it
First Name & Middle Initial & Last Name & Degree
Stefania Costi, PhD
Phone
00390522522441
Email
stefania.costi@unimore.it

12. IPD Sharing Statement

Learn more about this trial

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

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