Breast CancerVocRehabNCT05309265
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study
A study testing Multidisciplinary vocational rehabilitation intervention in people with Breast Cancer and Breast Neoplasm, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
In Italy, 50% of new breast cancer (BC) diagnosis occur in female of working age. Although return to work (RTW) is strongly desired by BC patients, cancer survivors are more likely to be unemployed than healthy individuals. Moreover, work difficulties may hindrance this process. Read more about this study
- Who is it for?
- Ages 18 to 67 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasm
- What is being tested?
- Multidisciplinary vocational rehabilitation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2022to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 67 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer diagnosis (regardless of stage and treatment)
- breast cancer patients in working age
- breast cancer patient who will participate to an educational group session held by the physiotherapists of the PMRU
- breast cancer patients with work difficulties
Who cannot join
- Breast cancer patients with work issues that cannot be addressed by any of the interventions (e.g., patients who would like to change their job)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Unità Sanitaria Locale Reggio Emilia
Reggio Emilia, Reggio Emilia, 42123
About this study
Official title: Multidisciplinary Vocational Rehabilitation Intervention to Support the Return to Work of Breast Cancer Patients: a Feasibility Study
In Italy, 50% of new breast cancer (BC) diagnosis occur in female of working age. Although return to work (RTW) is strongly desired by BC patients, cancer survivors are more likely to be unemployed than healthy individuals. Moreover, work difficulties may hindrance this process. Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. To date, the feasibility of the multidisciplinary vocational rehabilitation interventions has not been verified for BC patients.
Read the detailed description
BC is a public health burden with increasing trends in Western countries. In Italy, 50% of the new BC diagnosis have occurred in female of working age. Even though the return to work (RTW) is strongly desired, cancer survivors are 1.4 times more likely to be unemployed than healthy individuals. Furthermore, work difficulties may occur during this process. To promote the RTW, multidisciplinary interventions have shown moderate quality evidence in cancer survivors.
Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. During the implementation of the pathway, BC patients were referred mainly by the physiotherapists of the Physical Medicine and Rehabilitation Unit (PMRU). As standard care, BC patients can participate to an educational group session held by the physiotherapists after surgery. During this session, work difficulties have emerged.
Thus, the investigators aim to verify the feasibility of the multidisciplinary vocational rehabilitation intervention for a sample of BC patients whit work difficulties who will participate to an educational group session held by the physiotherapists.
- Conditions
- Breast Cancer, Breast Neoplasm
- Being tested
- Multidisciplinary vocational rehabilitation intervention
- Keywords
- Cancer Survivors, Return to work, Vocational Rehabilitation, Occupational Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary vocational rehabilitation interventionOther
- Information aims to provide tailored information concerning the work law protection (this support is already provided for all patients, regardless the type of disease, and also for citizens);
- Occupational therapy aims to facilitate the reintegration in the previous workplace through the development of a rehabilitation intervention to overcome work difficulties in agreement with employee, employer and occupational physician,
- Social support aims to find new job opportunities (for those who have lost the employment due to the disease) through the giving of support in job search, curriculum preparation, skill analysis, professional retraining and education.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with work difficulties | Other | Breast cancer patients with work difficulties can receive any of the three types of support, or a combination of these: information, occupational therapy and social support, in order to overcome barriers and return to work/continue to work Receives: Other: Multidisciplinary vocational rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
interception
rate of patients who has been proposed to participate to the feasibility study
Measured: 12 months
acceptation
rate of patients (who has been proposed to participate to the feasibility study) who accept to participate
Measured: 12 months
adherence
rate of patients who participate in the scheduled meeting and in the multidisciplinary intervention proposed; rate of patients who agree to receive the intervention at the workplace (for those eligible)
Measured: 12 months
lost to follow-up
rate of patients who will not attend the scheduled meeting (drop-out rate set ≤ 20%)
Measured: 12 months
satisfaction rate
rate of patients who perceive the modules of the multidisciplinary intervention as supportive for their RTW or work continuation
Measured: 12 months
RTW/work continuation
rate of patients who participate in the study and who will RTW or continued to work
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start7 Jul 2022
- Primary completion4 Aug 2023
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sara Paltrinieri, Msc OT, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309265
- Sponsor's protocol ID
- 2022/0035986
- Acronym
- VocRehab
- Status last verified
- Jun 2025
- First submitted
- 25 Mar 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paltrinieri S, Braglia L, Bravi F, Fugazzaro S, Costi S. A multidisciplinary intervention to support return to work of individuals with breast cancer: a prospective feasibility study. Support Care Cancer. 2026 Sep 16;34(10):979. doi: 10.1007/s00520-026-11198-5.
PubMed 42749939
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Vocational Rehabilitation Intervention to Support the Return to Work of Breast Cancer Patients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05309265
- Acronym / sponsor ID
- VocRehab / 2022/0035986
- Conditions
- Breast Cancer, Breast Neoplasm
- Keywords
- Cancer Survivors, Return to work, Vocational Rehabilitation, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Apr 2022 (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.
In Italy, 50% of new breast cancer (BC) diagnosis occur in female of working age. Although return to work (RTW) is strongly desired by BC patients, cancer survivors are more likely to be unemployed than healthy individuals. Moreover, work difficulties may hindrance this process. Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. To date, the feasibility of the multidisciplinary vocational rehabilitation interventions has not been verified for BC patients.
Detailed description
BC is a public health burden with increasing trends in Western countries. In Italy, 50% of the new BC diagnosis have occurred in female of working age. Even though the return to work (RTW) is strongly desired, cancer survivors are 1.4 times more likely to be unemployed than healthy individuals. Furthermore, work difficulties may occur during this process. To promote the RTW, multidisciplinary interventions have shown moderate quality evidence in cancer survivors.
Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. During the implementation of the pathway, BC patients were referred mainly by the physiotherapists of the Physical Medicine and Rehabilitation Unit (PMRU). As standard care, BC patients can participate to an educational group session held by the physiotherapists after surgery. During this session, work difficulties have emerged.
Thus, the investigators aim to verify the feasibility of the multidisciplinary vocational rehabilitation intervention for a sample of BC patients whit work difficulties who will participate to an educational group session held by the physiotherapists.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with work difficulties | Other | Other: Multidisciplinary vocational rehabilitation interventionBreast cancer patients with work difficulties can receive any of the three types of support, or a combination of these: information, occupational therapy and social support, in order to overcome barriers and return to work/continue to work |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- breast cancer diagnosis (regardless of stage and treatment)
- breast cancer patients in working age
- breast cancer patient who will participate to an educational group session held by the physiotherapists of the PMRU
- breast cancer patients with work difficulties
Key exclusion criteria (1 listed)
- Breast cancer patients with work issues that cannot be addressed by any of the interventions (e.g., patients who would like to change their job)
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 |
|---|---|---|
| Multidisciplinary vocational rehabilitation intervention* Information aims to provide tailored information concerning the work law protection (this support is already provided for all patients, regardless the type of disease, and also for citizens); * Occupational therapy aims to facilitate the reintegration in the previous workplace through the development of a rehabilitation intervention to overcome work difficulties in agreement with employee, employer and occupational physician, * Social support aims to find new job opportunities (for those who have lost the employment due to the disease) through the giving of support in job search, curriculum preparation, skill analysis, professional retraining and education. | Other | Breast cancer patients with work difficulties |
Primary outcome
interception
Time frame: 12 months
rate of patients who has been proposed to participate to the feasibility study
acceptation
Time frame: 12 months
rate of patients (who has been proposed to participate to the feasibility study) who accept to participate
adherence
Time frame: 12 months
rate of patients who participate in the scheduled meeting and in the multidisciplinary intervention proposed; rate of patients who agree to receive the intervention at the workplace (for those eligible)
lost to follow-up
Time frame: 12 months
rate of patients who will not attend the scheduled meeting (drop-out rate set ≤ 20%)
satisfaction rate
Time frame: 12 months
rate of patients who perceive the modules of the multidisciplinary intervention as supportive for their RTW or work continuation
RTW/work continuation
Time frame: 12 months
rate of patients who participate in the study and who will RTW or continued to work
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 42749939Paltrinieri S, Braglia L, Bravi F, Fugazzaro S, Costi S. A multidisciplinary intervention to support return to work of individuals with breast cancer: a prospective feasibility study. Support Care Cancer. 2026 Sep 16;34(10):979. doi: 10.1007/s00520-026-11198-5.
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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.
Sara Paltrinieri, Msc OT principal investigator
Azienda USL 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 Multidisciplinary vocational rehabilitation intervention in people with Breast Cancer and Breast Neoplasm, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
interception (time frame: 12 months). The study lists 6 primary outcomes in all. 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 NCT05309265, which also lists 1 linked publication.
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 7 May 2026.