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临床试验/CTRI/2019/06/019902
CTRI/2019/06/019902已完成不适用

Coping strategies in advanced lung cancer patients referred for specialist palliative care – validation of Brief COPE inventory in Hindi

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2019年1月7日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
340
试验地点
1
主要终点
Part I and II

研究概览

简要总结

Lung cancer is the most common cancer worldwide in males and females combined, accounting for 11.6% of the total cancer patients and  the leading cause of cancer death  accounting for 18.4% of the total cancer deaths. It is the expected to be the 6th most common cause of death by 2030. In India, according to GLOBOCAN 2018, approximately 70,000 new cases of lung cancer were estimated in male and female combined with a very high mortality rate.

At every stage of the disease, patients with lung cancer can find themselves dealing with distressing and difficult situations. They can develop various problems like sadness, depression and other psychological symptoms which can even interfere with their daily functioning.

Patients with incurable lung and gastrointestinal cancer who received Early Palliative Care (EPC) showed increased use of approach-oriented coping, associated with better Quality of Life and decreased negative symptoms like depression.

Most of the studies done in the area of coping strategies in advanced lung cancer are from developed countries where the sociodemographic scenarios are different from developing countries. The studies done in India on coping strategies have included advanced cancer patients in general. No studies have addressed coping strategies in advanced lung cancer patients specifically and in specialist palliative care setting, to the best of our knowledge.Also Brief COPE has not been validated in Hindi version for use in this group of patients.

The aim for this study is to validate the Brief COPE in Hindi language to assess the coping strategies of advanced lung cancer patients referred for specialist palliative care, in the context of a tertiary care cancer centre in a developing country.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with advanced lung cancer 2.Newly referred to Department of Palliative Medicine (outpatients and inpatients) or attending follow up (clinic based or home based) 3.Age above 18 years and willing to participate 4.Able to read and understand the appropriate language (English/Hindi) 5.Able to give written informed consent for face to face or telephonic contact for questionnaire administration.

排除标准

  • 1.Unstable medical/psychiatric condition requiring emergency treatment.
  • 2.Communication difficulties .
  • 3.Inability to read the questionnaire due to illiteracy.
  • 4.Inability to read the questionnaire due to cognitive or physical impairment .
  • 5.Patients presenting with acute symptoms requiring immediate medical attention.

结局指标

主要结局

Part I and II

时间窗: Only at First visit

Cultural adaptation of English version

时间窗: Only at First visit

Face validity

时间窗: Only at First visit

Translation of the Brief COPE into Hindi

时间窗: Only at First visit

Understandability, language, time to complete, etc of the questionnaire by 10% of the participants

时间窗: Only at First visit

Part III

时间窗: Only at First visit

Reliability of Brief COPE as measured by Cronbach’s alpha

时间窗: Only at First visit

Discriminant validity for construct validity.

时间窗: Only at First visit

Confirmatory Factor analysis

时间窗: Only at First visit

次要结局

  • NA(NA)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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