Facilitate the Return to Work of Cancer Survivors

Sponsor
Arcispedale Santa Maria Nuova-IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT03666936
Collaborator
(none)
26
1
1
21
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Social-health care intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Social-Healthcare Pathway to Facilitate Return to Work of Cancer Survivors in Italy: Implementation Process of the UNAMANO Project
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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) [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.

Secondary Outcome Measures

  1. difficulties faced by cancer patients in the return to work process, collected by a guided interview (Feasibility indicator_2). [through study completion, on average 24 months.]

    the difficulties arising from the guided interview will be analyzed qualitatively and categorized into emerging themes.

  2. ratio of cancer patients who have returned to work/not returned to work (Feasibility indicator_3). [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.

  3. number of healthcare providers directly informed about UNAMANO (Feasibility indicator_4). [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.

  4. number of healthcare professionals who refer patients to UNAMANO (Feasibility indicator_5). [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.

  5. number of individuals that contact In-Forma Salute to seek information regarding UNAMANO without being referred by a healthcare professional (Feasibility indicator_6). [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.

  6. number of volunteers informed about UNAMANO and recruited by UNAMANO (Feasibility indicator_7). [through study completion, on average 24 months.]

    we organize training events to recruit volunteers willing to support UNAMANO project.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • adults with cancer diagnosis and employed at the time of diagnosis
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Local Health Authority of Reggio Emilia-IRCCS Reggio Emilia Italy

Sponsors and Collaborators

  • Arcispedale Santa Maria Nuova-IRCCS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
COSTI STEFANIA, Clinical researcher, Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier:
NCT03666936
Other Study ID Numbers:
  • OCCA_Welcom_2017
First Posted:
Sep 12, 2018
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by COSTI STEFANIA, Clinical researcher, Arcispedale Santa Maria Nuova-IRCCS
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2021