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临床试验/CTRI/2025/11/097301
CTRI/2025/11/097301尚未招募不适用

Assessment of Psychological Distress in patients undergoing Oncological surgeries using Distress Thermometer

Dr Abhijeet Rathore1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To screen out patients with high psychological distress (DT score 4 or more), and provide them appropriate psychological support.

研究概览

简要总结

1.   Psychological distress is well known in patients undergoing oncological surgeries for gastro-intestinal, urological, head and neck, gynecological, neurological (CNS tumors) malignancies and other cancers like breast cancer, skin cancer like malignant melanoma. It adversely affects the quality of life and cancer care. Distress is associated with depression, anxiety, missed appointments, and adverse outcomes. The NCCN distress thermometer (DT) is a validated tool for its assessment. However, the same has not been documented much in Indian population. This study aims to fulfill the above paucity. The DT is a one-item,11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress). Patients are asked to indicate the number that best describes how much distress they have experienced over the past week, on a scale of 0 to 10. Further patients are prompted to choose problems which are causing them distress from the NCCN Problem list depicted on the right side of the tool. The NCCN Problem List for patients is a 43 - item supplemental list of potential sources of distress including physical, emotional, practical, social problems as well as spiritual/religious concerns. The established cutoff score for further screening is a 4.  Patients with a score of 4 or more, needs to be referred for further evaluation and management. Referrals can include psychologists, religious counsellors, and social workers.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All patients of newly diagnosed malignancies including pediatric patients capable of responding to DT.

排除标准

  • 1.Patients previously diagnosed as a case of Psychiatric illness.
  • 2.Patients with metastatic disease.

结局指标

主要结局

To screen out patients with high psychological distress (DT score 4 or more), and provide them appropriate psychological support.

时间窗: 02 years (Jan 2024 – Dec 2025)

次要结局

  • To use and validate DT for assessment of psychological distress in first-degree caregivers(02 years (Jan 2024 – Dec 2025))

研究者

发起方
Dr Abhijeet Rathore
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Abhijeet Rathore

Command Hospital, Lucknow

研究点 (1)

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