Breast CancerNEW-BreCaNCT05309252
The Unmet Needs and the Workplace Reintegration of Breast Cancer Patients: the NEW-BreCa Project
An observational study of Breast Cancer and Breast Neoplasms, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- How many people
- 113 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2022to 8 May 2024
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit breast cancer patients from those who will participate to an educational group session held by the physiotherapists of the Physical Medicine and Rehabilitation Unit (PMRU). Breast cancer patients who undergo surgery are offered to participate voluntarily in this educational group session after inpatients.
Who may be able to join
- 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.
Who cannot join
- breast cancer patients who do not speak fluently italian language
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Cancer Survivors, Unmet needs, Supportive care needs, Return to Work, Epidemiology, Observational study
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
occupational status
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
Measured: 12 months
work difficulties
the collection of the work-related difficulties that will be counted and classified using the Core Set-VR-Onco and, then, described qualitatively
Measured: 12 months
sick leave
the number of days of sick leave
Measured: 12 months
perceived needs
the identification of the perceived needs at first contact and at the following observations
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 start9 May 2022
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sara Paltrinieri, Azienda USL Reggio Emilia - IRCCS
- Investigators
- Sara Paltrinieri, Msc OT, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309252
- Sponsor's protocol ID
- 2022/0035983
- Acronym
- NEW-BreCa
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unmet Needs and the Workplace Reintegration of Breast Cancer Patients: the NEW-BreCa Project
- ClinicalTrials.gov ID
- NCT05309252
- Acronym / sponsor ID
- NEW-BreCa / 2022/0035983
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Cancer Survivors, Unmet needs, Supportive care needs, Return to Work, Epidemiology, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 9 May 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- 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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit breast cancer patients from those who will participate to an educational group session held by the physiotherapists of the Physical Medicine and Rehabilitation Unit (PMRU). Breast cancer patients who undergo surgery are offered to participate voluntarily in this educational group session after inpatients.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- breast cancer patients who do not speak fluently italian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occupational status
Time frame: 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
Time frame: 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
Time frame: 12 months
the number of days of sick leave
perceived needs
Time frame: 12 months
the identification of the perceived needs at first contact and at the following observations
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 15 Jul 2024.
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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?
An observational study of Breast Cancer and Breast Neoplasms, 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: finished, as of the sponsor's last update on 15 Jul 2024. 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?
occupational status (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2024.