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临床试验/NCT04439461
NCT04439461已完成不适用

Adaptation and First Step Validation of the International Classification of Functioning, Disability and Health Core Set for Vocational Rehabilitation for Cancer Survivors: A Sequential Mixed Method Study

Azienda Unità Sanitaria Locale Reggio Emilia1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年10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
140
试验地点
1
主要终点
1.a_Focus group

研究概览

简要总结

Return to work (RTW) of cancer survivors (CSs) is an emerging health issue, as cancer incidence, survival rate and prevalent cases have increasing trends and more than 1/3 of CSs are in their working age.

Starting from the International Classification of Functioning, Disability and Health (ICF), the Core Set for Vocational Rehabilitation (CS-VR) has been developed to comprehensively describe work functioning of individuals reporting difficulties and in need of VR. The CS-VR guides the multidisciplinary assessment of individuals and the planning of appropriate VR interventions but, to date, it has been tested only in spinal cord injury and musculoskeletal diseases. Thus, verifying the appropriateness of the CS-VR in a population of cancer survivors seems a step forward.

This sequential mixed method study aims to adapt and validate the CS-VR in Italian cancer survivors, defining the minimum standard of work functioning areas to assess in this population.

详细描述

Starting from the CS-VR, this study aims to define the CS-VR-Onco, an ICF core set consistent with cancer survivors' needs.

CS-VR-Onco will guide professionals in:

  1. comprehensively assessing work functioning
  2. identifying the areas of work functioning in which the VR intervention is relevant
  3. identifying patients who would benefit most from VR
  4. measuring work functioning pre-post VR

This sequential exploratory design involves multiple phases of qualitative (phase 1) and quantitative (phase 2) data collection.

Qualitative_phase 1, To adapt the CS-VR: 1.a_Focus groups (FGs) will be organized with CSs selected from the UNAMANO project (NCT03666936), the Cancer Registry of Reggio Emilia, the General Practitioners of the province of Reggio Emilia and the voluntary non-profit associations of cancer patients. During the FGs, we will ask participants to name and reflect on barriers and facilitators influencing their RTW process. Further, the FGs will address those ICF components from which the CS-VR categories were extracted. 1.b_Consensus-based approach with a sample of stakeholders of the RTW process. We will integrate evidence gathered from phase 1.a and the literature to develop the minimum standard for the assessment of work functioning in this population (CS-VR-Onco).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • cancer diagnosis
  • CSs employed at diagnosis

排除标准

  • comorbidities that limit communication or collaboration (i.e., aphasia, dementia, etc.)
  • non-melanoma skin cancer
  • Inclusion Criteria: Stakeholders who handle the RTW process: healthcare professionals, social workers, CSs, caregivers, employers, nonprofit associations, vocational counsellors, etc.

结局指标

主要结局

1.a_Focus group

时间窗: 3 months

To obtain the preliminary CS-VR-Onco, which categories will be subsequently analyzed by the group of stakeholders.

1.b_Consensus-based approach

时间窗: 3 months

To obtain the CS-VR-Onco, that is representative of minimum standard of work functioning areas to be assessed in cancer survivors in working age.

次要结局

  • 2.b_Longitudinal study(12 months)
  • 2.a_Cross-sectional survey(12 months)

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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