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临床试验/NCT05309252
NCT05309252已完成不适用

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

Azienda Unità Sanitaria Locale Reggio Emilia1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2022年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
occupational status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • breast cancer patients who do not speak fluently italian language

结局指标

主要结局

occupational status

时间窗: 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

sick leave

时间窗: 12 months

the number of days of sick leave

work difficulties

时间窗: 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

perceived needs

时间窗: 12 months

the identification of the perceived needs at first contact and at the following observations

次要结局

未报告次要终点

研究者

发起方
Azienda Unità Sanitaria Locale Reggio Emilia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sara Paltrinieri

MSc Occupational Therapist

Azienda Unità Sanitaria Locale Reggio Emilia

研究点 (1)

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