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临床试验/NCT04466631
NCT04466631Unknown不适用

SAlute e LaVoro in Chirurgia Oncologica (SALVO)

University of Padova2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Utilization of specific competences by participants

研究概览

简要总结

By using the M.A.D.I.T. methodology and the Dialogics science, SALVO Project aims to develop operational guidelines to support oncological target patients in the resumption of their daily post-operative activities. The research will implement an instrument for the purpose of measuring the health need of participants who are admitted to the surgical ward. Therefore, targeted interventions will be implemented with participants, and efficacy will be evaluated in order to define treatment guidelines.

The principal aim of this study is to create a validated and replicable intervention model for supporting patients who undergone surgery for esophageal and gastro intestinal cancer.

详细描述

Several studies highlight how patients diagnosed with a digestive tract cancer, experience difficulties in returning to work after treatment, leading to socio-economic spill-over effects.

A specific 16 questions questionnaire had been developed for this study, the "Health and Employment After Gastro Intestinal Surgery Dialogical Questionnaire" (HEADS-DQ). It investigate peculiar patient competences involved after surgery: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities.

Through this questionnaire participants ability in dealing with after surgery consequences will be evaluated in order to describe their development during the post surgery period.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • >18 years old;
  • Comprehension of Italian language;
  • Esophageal or gastrointestinal cancer diagnosis;
  • Curative surgery;
  • No metastasis or neoplasm recurrence.

排除标准

  • <18 years old;
  • No comprehension of Italian language;
  • Not esophageal or gastrointestinal cancer diagnosis;
  • Palliative surgery;
  • Metastasis or neoplasm recurrence.

结局指标

主要结局

Utilization of specific competences by participants

时间窗: 9 months after the surgery

Textual data derived from textual analysis: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities

次要结局

  • Number of participants maintaining their social activities(9 months after the surgery)
  • Number of participants maintaining their job(9 months after the surgery)
  • Number of participants with jejunostomy maintaining their job(9 months after the surgery)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (2)

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