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

Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05309265
Collaborator
(none)
25
1
1
23.8
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multidisciplinary vocational rehabilitation intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Multidisciplinary Vocational Rehabilitation Intervention to Support the Return to Work of Breast Cancer Patients: a Feasibility Study
Actual Study Start Date :
May 9, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Breast cancer patients with work difficulties

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

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.

Outcome Measures

Primary Outcome Measures

  1. interception [12 months]

    rate of patients who has been proposed to participate to the feasibility study

  2. acceptation [12 months]

    rate of patients (who has been proposed to participate to the feasibility study) who accept to participate

  3. adherence [12 months]

    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)

  4. lost to follow-up [12 months]

    rate of patients who will not attend the scheduled meeting (drop-out rate set ≤ 20%)

  5. satisfaction rate [12 months]

    rate of patients who perceive the modules of the multidisciplinary intervention as supportive for their RTW or work continuation

  6. RTW/work continuation [12 months]

    rate of patients who participate in the study and who will RTW or continued to work

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 67 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Unità Sanitaria Locale Reggio Emilia Reggio Emilia Italy 42123

Sponsors and Collaborators

  • Azienda Unità Sanitaria Locale Reggio Emilia

Investigators

  • Principal Investigator: Sara Paltrinieri, Msc OT, Azienda Unità Sanitaria Locale Reggio Emilia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Paltrinieri, MSc Occupational Therapist, Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier:
NCT05309265
Other Study ID Numbers:
  • 2022/0035986
First Posted:
Apr 4, 2022
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sara Paltrinieri, MSc Occupational Therapist, Azienda Unità Sanitaria Locale Reggio Emilia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022