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临床试验/NCT03546023
NCT03546023已完成不适用

Assessment of Quality of Life in Patients With Chronic Cancer Pain Using Brief Pain Inventory. A Prospective Observational Study

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2018年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
1
主要终点
Functional activity measurement using the Brief Pain Inventory (BPI)

研究概览

简要总结

Cancer-related pain has a major adverse impact on functional status and quality of life. Recently, a Survey conducted in 2015 in 10 Asian countries showed that among cancer patients in Asian population, 86% of patients reported that their pain affected their activities of daily living, 87% their sleep, 92% their concentration and focus, and 67% excessive reliance on others. Only 34% reported a good quality of life. Effective pain management may help the patient to focus on the positive aspects of life, decreasing the focus on pain and also promote better adherence to reasonable treatment plans. Hence the emphasis is on improving the Quality of Life and not mere pain control.

详细描述

This is a Prospective Observational Study. All new patients in chronic pain OPD are been administered BPI questionnaire as a standard of practice in our institute, in the language best understood by them e.g. English, Hindi, Marathi, Bengali. The participants will be asked to complete it once during their first visit to the pain clinic, before the start of treatment or ongoing treatment for pain (Baseline) and then during subsequent visits (Follow up). Most chronic pain patients are advised to follow-up by one to two weeks. Patients who are willing to participate in the study will be included after obtaining an informed consent. Data will be collected from BPI, Chronic Pain Record form and EMR and will be analyzed. Demographic data, diagnosis, pain data sheet, drug treatment as well as other form of therapies will be recorded. There will be no direct communication with the patient and data of quality of life will be retrieved from pain clinic records.

The Brief Pain Inventory (BPI) long form and short form questionnaire is a validated multidimensional pain assessment tool developed by Cleeland and Ryan. It is one of the most commonly used measures for assessing both pain severity and interference with functions in adults with cancer, thereby satisfying two recommendations (assessment of pain to include both intensity and interference) set by the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) group. It is brief, self administered, easily understood and can be administered to large numbers of patients,.

It contains three questions regarding pain intensity and seven regarding pain interference that are rated on an ordinal numerical scale with anchors of 0 (no pain/interference) to 10 (maximum pain/interference). Pain intensity is measured according to the worst pain experienced in the last three days, average pain in the last three days, and current pain. Pain interference assesses how that pain has affected general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The sum of the scores of the pain intensity items represents the summed pain intensity score and the sum of the scores on the pain interference items represents the summed interference score. In addition, the patient enters his pain localization on a body drawing and can give details of his current medication.

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
All
接受健康志愿者

入选标准

  • All patients registered in chronic pain OPD for 12 months from the date of approval of the study by IEC, at Tata Memorial Hospital.
  • Age ≥ 18 years

排除标准

  • Incomplete BPI forms.

结局指标

主要结局

Functional activity measurement using the Brief Pain Inventory (BPI)

时间窗: followup visit (minimum 7 days)

Any change in baseline score of functional activity from BPI during the followup visit.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Raghu Thota

Professor

Tata Memorial Hospital

研究点 (1)

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