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

NCT04439461 | Completed DMC

• 1 other identifier: CS-VR-ONCO_MFR_2020
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivors

Keywords

Vocational Rehabilitation; International Classification of Functioning, Disability and Health; Return to Work

Outcome Measures

Primary Outcomes (2)

• 1.a_Focus group

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

  3 months

• 1.b_Consensus-based approach

  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.

  3 months

Secondary Outcomes (2)

• 2.a_Cross-sectional survey

  12 months

• 2.b_Longitudinal study

  12 months

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1.a Focus Group: CSs will be recruited if the eligibility criteria reported below are satisfied. The Cancer Registry of Reggio Emilia will recruit CSs diagnosed in 2017 and who have already returned to work. 1.b Consensus-based approach: stakeholders (healthcare professionals, social workers, CSs, caregivers, employers, nonprofit associations, vocational counsellors, etc.) who handle the RTW process of CSs will be invited to participate. 2.a Cross-sectional study: CSs will be recruited if the eligibility criteria reported below are satisfied and diagnosis occurred in 2018. 2.b Longitudinal study: participants will be recruited if the eligibility criteria reported below are satisfied and cancer patients will be referred to UNAMANO for VR.

You may qualify if:

• cancer diagnosis
• CSs employed at diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Related Publications (1)

• 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.

  PMID: 35334038 DERIVED

Study Officials

• Sara Paltrinieri, Msc OT

  Azienda USL Reggio Emilia - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Occupational Therapist

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: October 9, 2020
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

IT (1)