Clinical Trials Directory

Trials / Completed

CompletedNCT04439461

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

Status
Completed
Phase
Study type
Observational
Enrollment
140 (actual)
Sponsor
Azienda USL Reggio Emilia - IRCCS · Other Government
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Accepted

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

Timeline

Start date
2020-10-09
Primary completion
2023-11-02
Completion
2023-11-02
First posted
2020-06-19
Last updated
2024-07-15

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04439461. Inclusion in this directory is not an endorsement.