Cancer SurvivorsNCT04439461
Adaptation and First Step Validation of the ICF Core Set for Vocational Rehabilitation for Cancer Survivors
An observational study of Cancer Survivors, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivors
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2020to 2 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Cancer Survivors
- Keywords
- Vocational Rehabilitation, International Classification of Functioning, Disability and Health, Return to Work
What is being measured
The primary outcome is the main question the study is designed to answer.
1.a_Focus group
To obtain the preliminary CS-VR-Onco, which categories will be subsequently analyzed by the group of stakeholders.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (2)
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).
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start9 Oct 2020
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sara Paltrinieri, Azienda USL Reggio Emilia - IRCCS
- Investigators
- Sara Paltrinieri, Msc OT, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439461
- Sponsor's protocol ID
- CS-VR-ONCO_MFR_2020
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2020
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paltrinieri S, Costi S, Pellegrini M, Diaz Crescitelli ME, Vicentini M, Mancuso P, Giorgi Rossi P, Fugazzaro S, Mazzini E, Escorpizo R, Ghirotto L. Adaptation of the Core Set for Vocational Rehabilitation for Cancer Survivors: A Qualitative Consensus-Based Study. J Occup Rehabil. 2022 Dec;32(4):718-730. doi: 10.1007/s10926-022-10033-y. Epub 2022 Mar 25.
PubMed 35334038
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04439461
- Acronym / sponsor ID
- CS-VR-ONCO_MFR_2020
- Conditions
- Cancer Survivors
- Keywords
- Vocational Rehabilitation, International Classification of Functioning, Disability and Health, Return to Work
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Inclusion Criteria: Stakeholders who handle the RTW process: healthcare professionals, social workers, CSs, caregivers, employers, nonprofit associations, vocational counsellors, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
2.a_Cross-sectional survey
Time frame: 12 months
2.b_Longitudinal study
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 35334038Paltrinieri S, Costi S, Pellegrini M, Diaz Crescitelli ME, Vicentini M, Mancuso P, Giorgi Rossi P, Fugazzaro S, Mazzini E, Escorpizo R, Ghirotto L. Adaptation of the Core Set for Vocational Rehabilitation for Cancer Survivors: A Qualitative Consensus-Based Study. J Occup Rehabil. 2022 Dec;32(4):718-730. doi: 10.1007/s10926-022-10033-y. Epub 2022 Mar 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Paltrinieri, Msc OT principal investigator
Azienda USL Reggio Emilia - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivors, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.a_Focus group (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.