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临床试验/NCT00971919
NCT00971919Unknown不适用

Prospective Cohort Study to Investigate Chronic Pain After Breast Cancer Surgery

Aberdeen Royal Infirmary1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
284
试验地点
1
主要终点
Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline

研究概览

简要总结

RATIONALE: Learning about chronic pain in women who have undergone surgery for breast cancer may help improve the quality of life for these patients and may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery for stage I, stage II, or stage III breast cancer.

详细描述

OBJECTIVES:

  • Identify which preoperative psychological risk factors, after controlling for demographic and clinical factors, are associated with chronic pain at 4 and 9 months after breast cancer surgery.
  • Assess the incidence of chronic pain at 4 and 9 months after breast cancer surgery.
  • Determine whether pain status at 4 and 9 months after breast cancer surgery is associated with changes in psychological well-being and health-related quality of life over time.

OUTLINE: This is a multicenter study.

Patients complete a preoperative pain questionnaire that includes the McGill Pain Questionnaire, a full body map, and the self-report Leeds Assessment of Neuropathic Symptoms and Signs scale. Only those patients with preoperative pain are asked to compete the full pain section of the questionnaire to assess location, severity, and type of pain. Acute postoperative pain during the first week after surgery is assessed using a visual analog scale (0-10). Patients then undergo telephone assessment of intensity and timing of acute pain 7 days after surgery. Subsequent postoperative pain assessments are conducted by mail using questionnaires at 4 and 9 months after surgery. Patients reporting chronic pain in the region of the surgical site are asked to complete the detailed pain section of the questionnaire.

Demographic variables, including age, education level, marital status, and body mass index, are recorded at baseline. Psychological (anxiety and exaggerated negative beliefs about pain) and quality-of-life outcomes are recorded at baseline and at 4 and 9 months postoperatively.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Association between chronic pain status at 4 and 9 months after surgery and differential changes in quality-of-life outcomes since baseline

Chronic pain at or near the surgical site persisting beyond the expected healing time as measured at 4 and 9 months after surgery

Identification of which psychological and quality of life variables, after controlling for baseline demographic, surgical, and other factors, are predictive of chronic pain at 4 and 9 months after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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