NCT03666936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

June 13, 2025

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

August 20, 2018

Last Update Submit

June 10, 2025

Conditions

Keywords

Cancer survivorsReturn to workItalyOccupational TherapyComprehensive Health CareNeoplasm

Outcome Measures

Primary Outcomes (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)

    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 Outcomes (6)

  • 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.

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

    through study completion, on average 24 months.

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

    through study completion, on average 24 months.

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

    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).

    through study completion, on average 24 months.

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Social-health care intervention

Other: Social-health care intervention

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Health Authority of Reggio Emilia-IRCCS

Reggio Emilia, Italy

Location

Related 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.

    PMID: 29845421BACKGROUND
  • 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.

    PMID: 31129762BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Elisa Mazzini

    Local Helath Authority of Reggio Emilia-IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

September 12, 2018

Study Start

May 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2021

Last Updated

June 13, 2025

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations