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

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ClinicalTrials.gov Identifier: NCT04439461
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Sara Paltrinieri, Azienda Unità Sanitaria Locale Reggio Emilia

Study Description
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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
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 Design
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Study Type : Observational
Estimated 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 : October 9, 2020
Actual Primary Completion Date : June 18, 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 1.a_Focus group [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.
Criteria

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439461


Contacts
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Contact: Sara Paltrinieri, Msc OT 00390522522416 sara.paltrinieri@ausl.re.it
Contact: Stefania Costi, PhD 00390522522441 stefania.costi@unimore.it

Locations
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Italy
Azienda Unità Sanitaria Locale Reggio Emilia Recruiting
Reggio Emilia, Italy, 42123
Contact: Sara Paltrinieri, BSc OT    00390522522416    sara.paltrinieri@ausl.re.it   
Contact: Stefania Costi, PhD    00390522522441    stefania.costi@unimore.it   
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Investigators
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Principal Investigator: Sara Paltrinieri, Msc OT Azienda Unità Sanitaria Locale Reggio Emilia
More Information
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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: June 19, 2020    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Paltrinieri, Azienda Unità Sanitaria Locale Reggio Emilia:
Vocational Rehabilitation
International Classification of Functioning, Disability and Health
Return to Work