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

Sponsor
Azienda Unità Sanitaria Locale Reggio Emilia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04439461
Collaborator
(none)
164
1
20.7
7.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    164 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    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
    Actual Study Start Date :
    Oct 9, 2020
    Actual Primary Completion Date :
    Jun 18, 2021
    Anticipated Study Completion Date :
    Jul 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 1.a_Focus group [3 months]

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

    2. 1.b_Consensus-based approach [3 months]

      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.

    Secondary Outcome Measures

    1. 2.a_Cross-sectional survey [12 months]

      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).

    2. 2.b_Longitudinal study [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Unità Sanitaria Locale Reggio Emilia Reggio Emilia Italy 42123

    Sponsors and Collaborators

    • Azienda Unità Sanitaria Locale Reggio Emilia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Paltrinieri, MSc Occupational Therapist, Azienda Unità Sanitaria Locale Reggio Emilia
    ClinicalTrials.gov Identifier:
    NCT04439461
    Other Study ID Numbers:
    • CS-VR-ONCO_MFR_2020
    First Posted:
    Jun 19, 2020
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sara Paltrinieri, MSc Occupational Therapist, Azienda Unità Sanitaria Locale Reggio Emilia

    Study Results

    No Results Posted as of Mar 24, 2022