Adaptation and First Step Validation of the ICF Core Set for Vocational Rehabilitation for Cancer Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04439461|
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : March 24, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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|
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:
- comprehensively assessing work functioning
- identifying the areas of work functioning in which the VR intervention is relevant
- identifying patients who would benefit most from VR
- 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|
|Estimated Enrollment :||164 participants|
|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|
- 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.
- 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.
- 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.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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||20 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- cancer diagnosis
- CSs employed at diagnosis
- comorbidities that limit communication or collaboration (i.e., aphasia, dementia, etc.)
- non-melanoma skin cancer
- Inclusion Criteria: Stakeholders who handle the RTW process: healthcare professionals, social workers, CSs, caregivers, employers, nonprofit associations, vocational counsellors, etc.
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
|Contact: Sara Paltrinieri, Msc OTfirstname.lastname@example.org|
|Contact: Stefania Costi, PhDemail@example.com|
|Azienda Unità Sanitaria Locale Reggio Emilia||Recruiting|
|Reggio Emilia, Italy, 42123|
|Contact: Sara Paltrinieri, BSc OT 00390522522416 firstname.lastname@example.org|
|Contact: Stefania Costi, PhD 00390522522441 email@example.com|
|Principal Investigator:||Sara Paltrinieri, Msc OT||Azienda Unità Sanitaria Locale Reggio Emilia|
|Responsible Party:||Sara Paltrinieri, MSc Occupational Therapist, Azienda Unità Sanitaria Locale Reggio Emilia|
|Other Study ID Numbers:||
|First Posted:||June 19, 2020 Key Record Dates|
|Last Update Posted:||March 24, 2022|
|Last Verified:||March 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
International Classification of Functioning, Disability and Health
Return to Work