The Unmet Needs and the Workplace Reintegration of Breast Cancer Patients: the NEW-BreCa Project

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05309252

Collaborator

(none)

115

Enrollment

Location

23.8

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Breast cancer (BC) have unmet needs that can impact negatively on participation in meaningful activities and the overall quality of life, if not addressed by the healthcare services. One of those needs is the return to work (RTW) for female in their working age.

The perceived needs of BC patients and RTW process might be influenced by sociodemographic data, disease-related, and work-related factors. Moreover, needs might change (type and priority) from diagnosis onwards. Prospective data regarding these topics have never been collected in Italian BC patients.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Neoplasms

Detailed Description

BC accounts for one of the highest worldwide public health burden, representing a population with increasing trends in Western countries. In Italy, BC is the most common diagnosis in female sex across all age groups, and the 50% were in their working age (between 20 and 64 years old).

Although early diagnostic methods and effective treatments offer BC patients a longer lifespan, the effects of therapies negatively impact on patients' daily lives and quality of life. BC patients might perceive variable needs (e.g., information, psychological) related to the experience of cancer and the care process that are considered as necessary to achieve goals in everyday life and return to normalcy. Unmet needs may arise when a gap occurs between a person's experience of healthcare services and the actual services require. Thus, care models for this population should be planned in the light of the most recent evidences.

Although the RTW is one of the necessities of BC patients, cancer survivors are more likely to be unemployed than healthy individuals and some difficulties may occur during the RTW process. Sociodemographic data, disease-related, and work-related factors might act as predictors of the unmet needs perceived by BC patients and the employment status from diagnosis onwards.

In Italy, unmet needs and RTW of BC patients have been investigated only through cross-sectional studies.

This type of study design does not allow to determine the causal relationship between potential determinants and unmet needs and occupational status, as well as the changes occurred from the diagnosis onwards. Prospective data regarding these topics have never been collected in Italian BC patients.

Thus, the investigators aim (1) to investigate the factors that could predict job loss, work difficulties, and long-term sick leave in BC patients of working age and (2) to investigate the factors that could predict the daily life needs of BC patients.

The investigators have planned a prospective data collection that will last 24 months. During the observations, the investigators will collect sociodemographic data, disease-related, and work-related factors.

Study Design

Study Type:

Observational

Anticipated Enrollment :

115 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Unmet Needs and the Workplace Reintegration of Breast Cancer Patients: the NEW-BreCa Project

Actual Study Start Date :

May 9, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Outcome Measures

Primary Outcome Measures

occupational status [12 months]
the identification of the occupational status at first contact and at the following observations. At each observation, we will ask the participants if they have returned to work or not
work difficulties [12 months]
the collection of the work-related difficulties that will be counted and classified using the Core Set-VR-Onco and, then, described qualitatively
sick leave [12 months]
the number of days of sick leave
perceived needs [12 months]
the identification of the perceived needs at first contact and at the following observations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

breast cancer diagnosis (regardless of stage and treatment)
breast cancer patients in adulthood (≥ 18 years)
breast cancer patient who will participate to an educational group session held by the physiotherapists of the PMRU

For patients who are not in working age or not employed at diagnosis, the work-related factors will not be collected.