Facilitate the Return to Work of Cancer Survivors

Neoplasms Clinical Trial

Official title:

A Social-Healthcare Pathway to Facilitate Return to Work of Cancer Survivors in Italy: Implementation Process of the UNAMANO Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666936
• Other study ID #: OCCA_Welcom_2017
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2021
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cancer patients could experience physical limitations, cognitive symptoms, fatigue and pain, that could be perceived at diagnosis but may also occur during treatment, limiting the person from carrying out their activities of daily living, including work tasks. Return to work is a major goal, as it facilitates the patient's ability to deal with the disease and improve general health. At present, there is no path aimed at supporting cancer patients in the return to work process. Because of this, the investigators want to assess the feasibility of a multidisciplinary social-health care pathway aimed at manage the difficulties that cancer patients might perceive in the return to work process.

Description:

To receive the support from the social-health care pathway, cancer survivors should go to an information desk service (called Informa Salute) located in the hospital. Here, sociodemographic and work-related data will be collected with the aim to organize the tailored social-health support to facilitate the return to work. The social-health care pathway created includes: the local Health Authority of Reggio Emilia and the local Order of Physicians, voluntary non-profit associations, vocational and educational training bodies, social cooperatives, one labor union and one chartered accountant enterprise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• adults with cancer diagnosis and employed at the time of diagnosis Exclusion Criteria: -

Related Conditions & MeSH terms

• Neoplasms
• Return to Work

Intervention

Other:
• Social-health care intervention
Cancer survivors enrolled in the study could receive support from the Occupational Therapist and/or from the social care professionist to overcome the difficulties encounter at work or to facilitate work reintegration.

Locations

Country	Name	City	State
Italy	Local Health Authority of Reggio Emilia-IRCCS	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Paltrinieri S, Vicentini M, Mazzini E, Ricchi E, Fugazzaro S, Mancuso P, Giorgi Rossi P, Costi S. Factors influencing return to work of cancer survivors: a population-based study in Italy. Support Care Cancer. 2020 Feb;28(2):701-712. doi: 10.1007/s00520-019-04868-0. Epub 2019 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number, type and duration of intervention provided (information, occupational therapy, social support) and, for those who have been offered the involvement of the employer, the number of those who have accepted this intervention (Feasibility indicator_1)	all the needs expressed by cancer patients and the related social-healthcare actions implemented will be recorded. To evaluate the feasibility of the social-healthcare pathway we will record the actions implemented successfully as well as the actions not implemented or ineffective.	through study completion, on average 24 months.
Secondary	difficulties faced by cancer patients in the return to work process, collected by a guided interview (Feasibility indicator_2).	the difficulties arising from the guided interview will be analyzed qualitatively and categorized into emerging themes.	through study completion, on average 24 months.
Secondary	ratio of cancer patients who have returned to work/not returned to work (Feasibility indicator_3).	we will calculate the ratio among cancer patients who received only information support and among those who received information support and occupational therapy.	through study completion, on average 24 months.
Secondary	number of healthcare providers directly informed about UNAMANO (Feasibility indicator_4).	during the project, training events and meetings were organized with the aim to inform all the healthcare professionals of the AUSL-IRCCS of Reggio Emilia involved in the care and management of cancer patients about UNAMANO project.	through study completion, on average 24 months.
Secondary	number of healthcare professionals who refer patients to UNAMANO (Feasibility indicator_5).	during the project, training events and meetings were organized with the aim to inform all the healthcare professionals of the AUSL-IRCCS of Reggio Emilia involved in the care and management of cancer patients about UNAMANO project.	through study completion, on average 24 months.
Secondary	number of individuals that contact In-Forma Salute to seek information regarding UNAMANO without being referred by a healthcare professional (Feasibility indicator_6).	we have distributed flyers in the hospitals throughout the Province, launched the website of the project and published news in local and national newspapers and on social media in order to raise awareness and provide information to the local community regarding UNAMANO.	through study completion, on average 24 months.
Secondary	number of volunteers informed about UNAMANO and recruited by UNAMANO (Feasibility indicator_7).	we organize training events to recruit volunteers willing to support UNAMANO project.	through study completion, on average 24 months.