Sara Paltrinieri, Msc OT

Stefania Costi, PhD

Sara Paltrinieri, BSc OT

Return to work (RTW) of cancer survivors (CSs) is an emerging health issue, as cancer incidence, survival rate and prevalent cases have increasing trends and more than 1/3 of CSs are in their working age.

Starting from the International Classification of Functioning, Disability and Health (ICF), the Core Set for Vocational Rehabilitation (CS-VR) has been developed to comprehensively describe work functioning of individuals reporting difficulties and in need of VR. The CS-VR guides the multidisciplinary assessment of individuals and the planning of appropriate VR interventions but, to date, it has been tested only in spinal cord injury and musculoskeletal diseases. Thus, verifying the appropriateness of the CS-VR in a population of cancer survivors seems a step forward.

This sequential mixed method study aims to adapt and validate the CS-VR in Italian cancer survivors, defining the minimum standard of work functioning areas to assess in this population.

Starting from the CS-VR, this study aims to define the CS-VR-Onco, an ICF core set consistent with cancer survivors' needs.

CS-VR-Onco will guide professionals in:

1. comprehensively assessing work functioning
2. identifying the areas of work functioning in which the VR intervention is relevant
3. identifying patients who would benefit most from VR
4. measuring work functioning pre-post VR

This sequential exploratory design involves multiple phases of qualitative (phase 1) and quantitative (phase 2) data collection.

Qualitative_phase 1, To adapt the CS-VR: 1.a_Focus groups (FGs) will be organized with CSs selected from the UNAMANO project (NCT03666936), the Cancer Registry of Reggio Emilia, the General Practitioners of the province of Reggio Emilia and the voluntary non-profit associations of cancer patients. During the FGs, we will ask participants to name and reflect on barriers and facilitators influencing their RTW process. Further, the FGs will address those ICF components from which the CS-VR categories were extracted. 1.b_Consensus-based approach with a sample of stakeholders of the RTW process. We will integrate evidence gathered from phase 1.a and the literature to develop the minimum standard for the assessment of work functioning in this population (CS-VR-Onco).

Quantitative_phase 2, To validate the CS-VR-Onco: 2.a_Cross-sectional survey of CSs extracted from the Cancer Registry of Reggio Emilia. Through a guided interview based on the categories of the CS-VR-Onco, we will ask participants to report their work difficulties. 2.b_Longitudinal study on cancer patients recently diagnosed with cancer referred to UNAMANO project for VR. Before and after the VR, CS-VR-Onco will be administer to identify patients' needs. Additionally, participants will be assessed with valid measurement tools (when present) pertinent to the CS-VR-Onco categories identified.

Adaptation and First Step Validation of the ICF Core Set for Vocational Rehabilitation for Cancer Survivors

Adaptation and First Step Validation of the International Classification of Functioning, Disability and Health Core Set for Vocational Rehabilitation for Cancer Survivors: A Sequential Mixed Method Study

To obtain the preliminary CS-VR-Onco, which categories will be subsequently analyzed by the group of stakeholders.

To obtain the CS-VR-Onco, that is representative of minimum standard of work functioning areas to be assessed in cancer survivors in working age.

To describe the frequency of distribution of the categories included in the CS-VR-Onco (content validity) and to compare those distributions between CSs who did and those who did not experience difficulties in the RTW process (construct validity).

To verify whether the CS-VR-Onco can appropriately identify the categories in which VR is of main relevance and detect changes over time.

Azienda Unità Sanitaria Locale Reggio Emilia

MSc Occupational Therapist

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

* 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.

Multidisciplinary vocational rehabilitation intervention

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.

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.

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

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

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

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

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)

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adaptation and First Step Validation of the ICF Core Set for Vocational Rehabilitation for Cancer Survivors	NCT04439461	Cancer Survivor...		20 Years - 60 Years	Azienda Unità Sanitaria Locale Reggio Emilia
Adaptation and First Step Validation of the ICF Core Set for Vocational Rehabilitation for Cancer Survivors	NCT04439461	Cancer Survivor...		20 Years - 60 Years	Azienda Unità Sanitaria Locale Reggio Emilia
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study	NCT05309265	Breast Cancer Breast Neoplasm	Multidisciplina...	18 Years - 67 Years	Azienda Unità Sanitaria Locale Reggio Emilia
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study	NCT05309265	Breast Cancer Breast Neoplasm	Multidisciplina...	18 Years - 67 Years	Azienda Unità Sanitaria Locale Reggio Emilia

Spots Global Cancer Trial Database for vocational rehabilitation