NeoplasmsNCT03666936
Facilitate the Return to Work of Cancer Survivors
A study testing Social-health care intervention in people with Neoplasms and Return to Work, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms, Return to Work
- What is being tested?
- Social-health care intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2018to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adults with cancer diagnosis and employed at the time of diagnosis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasms, Return to Work
- Being tested
- Social-health care intervention
- Keywords
- Cancer survivors, Return to work, Italy, Occupational Therapy, Comprehensive Health Care, Neoplasm
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social-health care interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Social-health care intervention Receives: Other: Social-health care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
the difficulties arising from the guided interview will be analyzed qualitatively and categorized into emerging themes.
Measured: through study completion, on average 24 months.
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.
Measured: through study completion, on average 24 months.
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.
Measured: through study completion, on average 24 months.
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.
Measured: 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).
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.
Measured: through study completion, on average 24 months.
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.
Measured: through study completion, on average 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 May 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elisa Mazzini, Principal investigator, Local Helath Authority of Reggio Emilia-IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666936
- Sponsor's protocol ID
- OCCA_Welcom_2017
- Status last verified
- Jul 2021
- First submitted
- 20 Aug 2018
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29845421Paltrinieri 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.
PubMed 31129762
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Social-Healthcare Pathway to Facilitate Return to Work of Cancer Survivors in Italy: Implementation Process of the UNAMANO Project
- ClinicalTrials.gov ID
- NCT03666936
- Acronym / sponsor ID
- OCCA_Welcom_2017
- Conditions
- Neoplasms, Return to Work
- Keywords
- Cancer survivors, Return to work, Italy, Occupational Therapy, Comprehensive Health Care, Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Social-health care interventionSocial-health care intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adults with cancer diagnosis and employed at the time of diagnosis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social-health care interventionCancer 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. | Other | Intervention |
Primary outcome
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.
6 secondary outcomes
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.
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.
number of healthcare providers directly informed about UNAMANO (Feasibility indicator_4).
Time frame: 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.
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.
number of volunteers informed about UNAMANO and recruited by UNAMANO (Feasibility indicator_7).
Time frame: through study completion, on average 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 29845421Paltrinieri 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.
- Background: PubMed 31129762Paltrinieri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Mazzini principal investigator
Local Helath Authority of Reggio Emilia-IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social-health care intervention in people with Neoplasms and Return to Work, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666936, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.