Facilitate the Return to Work of Cancer Survivors

July 24, 2021 updated by: COSTI STEFANIA, Arcispedale Santa Maria Nuova-IRCCS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Local Health Authority of Reggio Emilia-IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults with cancer diagnosis and employed at the time of diagnosis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Social-health care 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: through study completion, on average 24 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
difficulties faced by cancer patients in the return to work process, collected by a guided interview (Feasibility indicator_2).
Time Frame: through study completion, on average 24 months.
the difficulties arising from the guided interview will be analyzed qualitatively and categorized into emerging themes.
through study completion, on average 24 months.
ratio of cancer patients who have returned to work/not returned to work (Feasibility indicator_3).
Time Frame: through study completion, on average 24 months.
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.
number of healthcare providers directly informed about UNAMANO (Feasibility indicator_4).
Time Frame: through study completion, on average 24 months.
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.
number of healthcare professionals who refer patients to UNAMANO (Feasibility indicator_5).
Time Frame: through study completion, on average 24 months.
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.
number of individuals that contact In-Forma Salute to seek information regarding UNAMANO without being referred by a healthcare professional (Feasibility indicator_6).
Time Frame: through study completion, on average 24 months.
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.
number of volunteers informed about UNAMANO and recruited by UNAMANO (Feasibility indicator_7).
Time Frame: through study completion, on average 24 months.
we organize training events to recruit volunteers willing to support UNAMANO project.
through study completion, on average 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcispedale Santa Maria Nuova-IRCCS

Investigators

  • Principal Investigator: Elisa Mazzini, Local Helath Authority of Reggio Emilia-IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 24, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCCA_Welcom_2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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