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

Cancer Survivors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04439461
• Other study ID #: CS-VR-ONCO_MFR_2020
• Status: Recruiting
• Start date: October 9, 2020
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: Sara Paltrinieri, Msc OT
• Phone: 00390522522416
• Email: sara.paltrinieri[@]ausl.re.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: June 2024
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Survivors

Locations

Country	Name	City	State
Italy	Azienda Unità Sanitaria Locale Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.a_Focus group	To obtain the preliminary CS-VR-Onco, which categories will be subsequently analyzed by the group of stakeholders.	3 months
Primary	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	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
Secondary	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