Cancer Survivorsemployers_2024NCT06994182
Perspectives of Italian Employers Regarding the Return to Work Process of Employees Who Received a Cancer Diagnosis: a Qualitative Study
An observational study of Cancer Survivors, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
European Cancer Mission calls attention to the return to work (RTW) of cancer survivors (CSs), as one of the pivotal issues of the cancer continuum that need to be addressed through proper and prompt actions and recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of employers of the province of Reggio Emilia who managed the RTW process of employees with a cancer diagnosis. This population includes employers from companies with diverse characteristics (type of company and sector, and number of employees) to collect the perspectives of employers working in different settings.
Who may be able to join
- employers* of a company
- being directly involved in managing the RTW process of at least one employee with cancer diagnosis in the last 5 years.
- An employer can be the specific person who represents the company where the employee was working at the time of cancer diagnosis or a person who supported the employee during the sickness absence and the RTW process (e.g., line manager, human resource manager).
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, 42123
Sara Paltrinieri, PhD, OT, sara.paltrinieri@ausl.re.it
About this study
European Cancer Mission calls attention to the return to work (RTW) of cancer survivors (CSs), as one of the pivotal issues of the cancer continuum that need to be addressed through proper and prompt actions and recommendations. Employers are important stakeholders, as they can provide emotional and practical support, sustain communication during the entire process, and guarantee a gradual work reintegration. In Italy there is lack of knowledge regarding this topic. Thus, further exploration of Italian employers' perspectives on the RTW of employees with cancer should be performed to comprehend their unknown experiences.
The aim is to explore the perspectives of employers who dealt with the RTW process of employees who received a cancer diagnosis through a qualitative research design.
Read the detailed description
Data collection will be performed through individual semi-structured interviews. Each interview will last around 60 minutes, and it can be arranged in person or remotely, depending on the participant's preference. Socio-demographic data, expertise of the employer, and company-related data will be collected through a semi-structured interview.
Experiences of employers will be collected through open-ended questions using an interview guide that was written based on the one used by Tiedtke et al., 2017, by adding some questions related to the facilitators and barriers perceived by employers during the sickness absence and RTW of employee with cancer.
The open-ended questions will concern general information about the company, employers' experience after cancer disclosure and during sick leave, employers' experience to sustain the RTW process and the long-term work reintegration, and the influence of the experience on the company.
Each interview will be audio-recorded, transcribed verbatim and analyzed according to the thematic analysis method using an inductive approach with open coding.
Analysis will be iterative and involve multiple researchers to ensure inter-rater reliability of the coding procedure and the methodological rigor of the analysis.
Themes generated will be discussed with Dutch researchers from the Amsterdam University Medical Centers.
Analyses will be carried out at the end of each interview because, based on the themes that will emerge from each interview, we will understand when to stop recruiting.
- Conditions
- Cancer Survivors
- Keywords
- Cancer Survivors, Return to work, Employers, Qualitative Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Employers | This cohort includes employers of active companies located in the province of Reggio Emilia. The Chamber of Commerce dell 'Emilia will provide a random list of the active company based on the type of company (profit, non-for-profit), type of sector (i.e., manufacturing, constructions), and number of employees (small, medium, large) to guarantee the representativeness of our context. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Open-ended questions of a semi-structured interview to collect the employers experience of the management of the RTW process
Themes describing how employers managed the RTW process of employees with cancer, of their feeling and thoughts, of what actions did they do, and of the relationships and communication with the other members of the company
Measured: 12 months
Open-ended questions of a semi-structured interview to collect the employers' necessities while supporting the RTW process
Themes describing what employers require to support employees who receive a cancer diagnosis in the RTW process
Measured: 12 months
Open-ended questions of a semi-structured interview to collect the employers perceived barriers and facilitators while supporting the RTW process
Themes describing the facilitators and barriers perceived by employers during the RTW process of employees who received a cancer diagnosis. For this outcome, themes will be classified using the Resource Dependence Institutional Cooperation (RDIC) model, developed by Rijk et al. and adjusted by Greidanus et al. (2018).
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 posted29 May 2025
- Study start1 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Responsible party
- Sponsor
- Investigators
- Sara Paltrinieri, PhD, OT, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994182
- Sponsor's protocol ID
- 632/2024/OSS/AUSLRE
- Acronym
- employers_2024
- Status last verified
- Aug 2025
- First submitted
- 20 May 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greidanus MA, de Boer AGEM, de Rijk AE, Tiedtke CM, Dierckx de Casterle B, Frings-Dresen MHW, Tamminga SJ. Perceived employer-related barriers and facilitators for work participation of cancer survivors: A systematic review of employers' and survivors' perspectives. Psychooncology. 2018 Mar;27(3):725-733. doi: 10.1002/pon.4514. Epub 2017 Sep 6.
PubMed 28753741Lawler M, De Lorenzo F, Lagergren P, Mennini FS, Narbutas S, Scocca G, Meunier F; European Academy of Cancer Sciences. Challenges and solutions to embed cancer survivorship research and innovation within the EU Cancer Mission. Mol Oncol. 2021 Jul;15(7):1750-1758. doi: 10.1002/1878-0261.13022. Epub 2021 Jun 15.
PubMed 34053182Paltrinieri S, Fugazzaro S, Bertozzi L, Bassi MC, Pellegrini M, Vicentini M, Mazzini E, Costi S. Return to work in European Cancer survivors: a systematic review. Support Care Cancer. 2018 Sep;26(9):2983-2994. doi: 10.1007/s00520-018-4270-6. Epub 2018 May 29.
PubMed 29845421de Rijk A, Amir Z, Cohen M, Furlan T, Godderis L, Knezevic B, Miglioretti M, Munir F, Popa AE, Sedlakova M, Torp S, Yagil D, Tamminga S, de Boer A. The challenge of return to work in workers with cancer: employer priorities despite variation in social policies related to work and health. J Cancer Surviv. 2020 Apr;14(2):188-199. doi: 10.1007/s11764-019-00829-y. Epub 2019 Nov 22.
PubMed 31758518Tiedtke CM, Dierckx de Casterle B, Frings-Dresen MHW, De Boer AGEM, Greidanus MA, Tamminga SJ, De Rijk AE. Employers' experience of employees with cancer: trajectories of complex communication. J Cancer Surviv. 2017 Oct;11(5):562-577. doi: 10.1007/s11764-017-0626-z. Epub 2017 Jul 14.
PubMed 28710544
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives of Italian Employers Regarding the Return to Work Process of Employees Who Received a Cancer Diagnosis: a Qualitative Study
- ClinicalTrials.gov ID
- NCT06994182
- Acronym / sponsor ID
- employers_2024 / 632/2024/OSS/AUSLRE
- Conditions
- Cancer Survivors
- Keywords
- Cancer Survivors, Return to work, Employers, Qualitative Research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 May 2025 (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.
European Cancer Mission calls attention to the return to work (RTW) of cancer survivors (CSs), as one of the pivotal issues of the cancer continuum that need to be addressed through proper and prompt actions and recommendations. Employers are important stakeholders, as they can provide emotional and practical support, sustain communication during the entire process, and guarantee a gradual work reintegration. In Italy there is lack of knowledge regarding this topic. Thus, further exploration of Italian employers' perspectives on the RTW of employees with cancer should be performed to comprehend their unknown experiences.
The aim is to explore the perspectives of employers who dealt with the RTW process of employees who received a cancer diagnosis through a qualitative research design.
Detailed description
Data collection will be performed through individual semi-structured interviews. Each interview will last around 60 minutes, and it can be arranged in person or remotely, depending on the participant's preference. Socio-demographic data, expertise of the employer, and company-related data will be collected through a semi-structured interview.
Experiences of employers will be collected through open-ended questions using an interview guide that was written based on the one used by Tiedtke et al., 2017, by adding some questions related to the facilitators and barriers perceived by employers during the sickness absence and RTW of employee with cancer.
The open-ended questions will concern general information about the company, employers' experience after cancer disclosure and during sick leave, employers' experience to sustain the RTW process and the long-term work reintegration, and the influence of the experience on the company.
Each interview will be audio-recorded, transcribed verbatim and analyzed according to the thematic analysis method using an inductive approach with open coding.
Analysis will be iterative and involve multiple researchers to ensure inter-rater reliability of the coding procedure and the methodological rigor of the analysis.
Themes generated will be discussed with Dutch researchers from the Amsterdam University Medical Centers.
Analyses will be carried out at the end of each interview because, based on the themes that will emerge from each interview, we will understand when to stop recruiting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Employers | – | –This cohort includes employers of active companies located in the province of Reggio Emilia. The Chamber of Commerce dell 'Emilia will provide a random list of the active company based on the type of company (profit, non-for-profit), type of sector (i.e., manufacturing, constructions), and number of employees (small, medium, large) to guarantee the representativeness of our context. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of employers of the province of Reggio Emilia who managed the RTW process of employees with a cancer diagnosis. This population includes employers from companies with diverse characteristics (type of company and sector, and number of employees) to collect the perspectives of employers working in different settings.
Key inclusion criteria (3 listed)
- employers* of a company
- being directly involved in managing the RTW process of at least one employee with cancer diagnosis in the last 5 years.
Key exclusion criteria (1 listed)
- none
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. Open-ended questions of a semi-structured interview to collect the employers experience of the management of the RTW process
Time frame: 12 months
Themes describing how employers managed the RTW process of employees with cancer, of their feeling and thoughts, of what actions did they do, and of the relationships and communication with the other members of the company
Open-ended questions of a semi-structured interview to collect the employers' necessities while supporting the RTW process
Time frame: 12 months
Themes describing what employers require to support employees who receive a cancer diagnosis in the RTW process
Open-ended questions of a semi-structured interview to collect the employers perceived barriers and facilitators while supporting the RTW process
Time frame: 12 months
Themes describing the facilitators and barriers perceived by employers during the RTW process of employees who received a cancer diagnosis. For this outcome, themes will be classified using the Resource Dependence Institutional Cooperation (RDIC) model, developed by Rijk et al. and adjusted by Greidanus et al. (2018).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 28753741Greidanus MA, de Boer AGEM, de Rijk AE, Tiedtke CM, Dierckx de Casterle B, Frings-Dresen MHW, Tamminga SJ. Perceived employer-related barriers and facilitators for work participation of cancer survivors: A systematic review of employers' and survivors' perspectives. Psychooncology. 2018 Mar;27(3):725-733. doi: 10.1002/pon.4514. Epub 2017 Sep 6.
- Background: PubMed 34053182Lawler M, De Lorenzo F, Lagergren P, Mennini FS, Narbutas S, Scocca G, Meunier F; European Academy of Cancer Sciences. Challenges and solutions to embed cancer survivorship research and innovation within the EU Cancer Mission. Mol Oncol. 2021 Jul;15(7):1750-1758. doi: 10.1002/1878-0261.13022. Epub 2021 Jun 15.
- Background: PubMed 29845421Paltrinieri S, Fugazzaro S, Bertozzi L, Bassi MC, Pellegrini M, Vicentini M, Mazzini E, Costi S. Return to work in European Cancer survivors: a systematic review. Support Care Cancer. 2018 Sep;26(9):2983-2994. doi: 10.1007/s00520-018-4270-6. Epub 2018 May 29.
- Background: PubMed 31758518de Rijk A, Amir Z, Cohen M, Furlan T, Godderis L, Knezevic B, Miglioretti M, Munir F, Popa AE, Sedlakova M, Torp S, Yagil D, Tamminga S, de Boer A. The challenge of return to work in workers with cancer: employer priorities despite variation in social policies related to work and health. J Cancer Surviv. 2020 Apr;14(2):188-199. doi: 10.1007/s11764-019-00829-y. Epub 2019 Nov 22.
- Background: PubMed 28710544Tiedtke CM, Dierckx de Casterle B, Frings-Dresen MHW, De Boer AGEM, Greidanus MA, Tamminga SJ, De Rijk AE. Employers' experience of employees with cancer: trajectories of complex communication. J Cancer Surviv. 2017 Oct;11(5):562-577. doi: 10.1007/s11764-017-0626-z. Epub 2017 Jul 14.
- Individual participant dataSharing planned: No
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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.
Sara Paltrinieri, PhD, 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Paltrinieri, PhD, OT (0039 0522 522416, sara.paltrinieri@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Open-ended questions of a semi-structured interview to collect the employers experience of the management of the RTW process (time frame: 12 months). The study lists 3 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 NCT06994182, which also lists 5 linked publications.
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 29 Aug 2025.