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

NCT ID: NCT04439461

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-09
• Study Completion Date: 2023-11-02

Brief Summary

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.

Detailed Description

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.

Conditions

Cancer Survivors

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• cancer diagnosis
• CSs employed at diagnosis

Exclusion Criteria

• comorbidities that limit communication or collaboration (i.e., aphasia, dementia, etc.)
• non-melanoma skin cancer

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sara Paltrinieri

MSc Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Paltrinieri, Msc OT

Role: PRINCIPAL_INVESTIGATOR

Azienda USL Reggio Emilia - IRCCS

Locations

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, , Italy

Countries

Italy

References

Paltrinieri S, Costi S, Pellegrini M, Diaz Crescitelli ME, Vicentini M, Mancuso P, Giorgi Rossi P, Fugazzaro S, Mazzini E, Escorpizo R, Ghirotto L. Adaptation of the Core Set for Vocational Rehabilitation for Cancer Survivors: A Qualitative Consensus-Based Study. J Occup Rehabil. 2022 Dec;32(4):718-730. doi: 10.1007/s10926-022-10033-y. Epub 2022 Mar 25.

Reference Type: DERIVED

PMID: 35334038 (View on PubMed)

Other Identifiers

CS-VR-ONCO_MFR_2020

Identifier Type: -

Identifier Source: org_study_id