NCT05309265

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
6mo left

Started Jul 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress90%
Jul 2022Nov 2026

First Submitted

Initial submission to the registry

March 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 7, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2023

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

May 7, 2026

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

March 25, 2022

Last Update Submit

May 4, 2026

Conditions

Breast CancerBreast Neoplasm

Keywords

Cancer SurvivorsReturn to workVocational RehabilitationOccupational Therapy

Outcome Measures

Primary Outcomes (6)

  • interception

    rate of patients who has been proposed to participate to the feasibility study

    12 months

  • acceptation

    rate of patients (who has been proposed to participate to the feasibility study) who accept to participate

    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)

    12 months

  • lost to follow-up

    rate of patients who will not attend the scheduled meeting (drop-out rate set ≤ 20%)

    12 months

  • satisfaction rate

    rate of patients who perceive the modules of the multidisciplinary intervention as supportive for their RTW or work continuation

    12 months

  • RTW/work continuation

    rate of patients who participate in the study and who will RTW or continued to work

    12 months

Study Arms (1)

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

Other: Multidisciplinary vocational rehabilitation intervention

Interventions

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.

Breast cancer patients with work difficulties

Eligibility Criteria

Age18 Years - 67 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, Reggio Emilia, 42123, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sara Paltrinieri, Msc OT

    Azienda USL Reggio Emilia - IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 4, 2022

Study Start

July 7, 2022

Primary Completion

August 4, 2023

Study Completion (Estimated)

November 30, 2026

Last Updated

May 7, 2026

Record last verified: 2025-06

Locations

IT(1)