Clinical trial NCT06994182: Perspectives of Italian Employers Regarding the Return to Work Process of Employees Who Received a Cancer Diagnosis: a Qualitative Study
Official title: Perspectives of Italian Employers Regarding the Return to Work Process of Employees Who Received a Cancer Diagnosis: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer Survivors
Keywords: Cancer Survivors
Return to work
Employers
Qualitative Research
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
First posted: 2025-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. employers\* of a company
2. 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).

Exclusion Criteria:

* none

Primary outcomes:
measure: 1. Open-ended questions of a semi-structured interview to collect the employers experience of the management of the RTW process
timeFrame: 12 months
measure: Open-ended questions of a semi-structured interview to collect the employers' necessities while supporting the RTW process
timeFrame: 12 months
measure: Open-ended questions of a semi-structured interview to collect the employers perceived barriers and facilitators while supporting the RTW process
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
state: RE
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Sara Paltrinieri, PhD, OT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lawler 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.
citation: Paltrinieri 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.
citation: de 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.
citation: Tiedtke 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.