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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Survivors

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.

• Study Type: Observational
• Enrollment (Estimated): 164

Contacts and Locations

• Study Contact: Name: Sara Paltrinieri, Msc OT; Phone Number: 00390522522416; Email: sara.paltrinieri@ausl.re.it
• Study Contact Backup: Name: Stefania Costi, PhD; Phone Number: 00390522522441; Email: stefania.costi@unimore.it

Study Locations

• Italy
  • Reggio Emilia, Italy, 42123
    • Recruiting
    • Azienda Unità Sanitaria Locale Reggio Emilia
    • Contact: Stefania Costi, PhD; Phone Number: 00390522522441; Email: stefania.costi@unimore.it
    • Contact: Sara Paltrinieri, BSc OT; Phone Number: 00390522522416; Email: sara.paltrinieri@ausl.re.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

1. 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
2. Inclusion Criteria: Stakeholders who handle the RTW process: healthcare professionals, social workers, CSs, caregivers, employers, nonprofit associations, vocational counsellors, etc.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2.a_Cross-sectional survey	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).	12 months
2.b_Longitudinal study	To verify whether the CS-VR-Onco can appropriately identify the categories in which VR is of main relevance and detect changes over time.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Actual): June 18, 2021
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: International Classification of Functioning, Disability and Health; Return to Work; Vocational Rehabilitation
• Other Study ID Numbers: CS-VR-ONCO_MFR_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No