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临床试验/NCT04989179
NCT04989179进行中(未招募)不适用

Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome - A Multi-centre Prospective Cohort Study.

Singapore General Hospital3 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2021年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
220
试验地点
3
主要终点
Precise estimate of the local incidence and clinical/functional impact of PMPS

研究概览

简要总结

This multi-centre, prospective study aims to obtain a precise estimate of the local incidence of PMPS and identify biopsychosocial risk factors contributing to the development of PMPS. Recognition of the impact of PMPS on function and mood and quality of life in cancer survivors, and identification of risk factors would help physicians institute appropriate pre-operative counselling and preventive measures to reduce the development of PMPS. The investigators aim to follow up on the long-term multi-dimensional effects of PMPS, and continue to develop and validate a risk prediction model for patients at risk of PMPS in the next phase of the study.

详细描述

Post-mastectomy pain syndrome (PMPS) has been reported to occur in 25-60% of patients following surgeries for breast cancer, the highest occurring cancer in women worldwide. There is a lack of an accepted standard definition of PMPS which has resulted in the wide range of estimates of its occurrence. While there has been much research interest in this condition, there is still a paucity of standardized and effective treatment at this point, and our understanding of this condition, its exact incidence and risk factors, is still incomplete.

The local incidence of PMPS after breast cancer surgery is presently unknown and often under-reported, although breast cancer surgery is common and is carried out in almost all Singhealth institutions. Risk factors for PMPS in the local context may differ from that postulated in the West due to cultural, racial and societal differences. Breast cancer has a high survival rate, with data from the CONCORD-2 study showing a 5-year survival rate of ≥85% in developed countries. Despite high survival rates in cancer survivors, PMPS has been shown to have a negative impact on the quality of recovery (QoR), patient satisfaction, and can be severe enough causing the diminished quality of life (QoL) including poor sleep, long-term disability, mood disorders and interference with activities of daily living (ADL).

Despite widespread recognition of PMPS, it is often untreated or undertreated. Some possible reasons suggested for inadequate management of PMPS are the lack of quality information about optimal treatment, and incomplete understanding of the mechanisms and risk factors for chronic pain development and prognosis. There is a knowledge gap in the understanding of risk factors leading to PMPS, the lack of a validated risk prediction model for development of PMPS, and hence limiting the institution of preventive analgesia in high risk patients. It is therefore timely to conduct a local multi-centre, prospective study to look at the local incidence of PMPS after breast surgery, the multi-dimensional effects of PMPS on the patient as well as to identify modifiable biopsychosocial risk factors leading to PMPS.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 21-80 years old
  • Provided consent for the study
  • Types of breast surgery included: single or bilateral site mastectomies, with or without axillary clearance, wide excision with axillary clearance, radical mastectomies with or without flap surgery.

排除标准

  • Age below 21 or above 80 years old
  • Male patients
  • Cognitive impairment/ uncommunicative patients.

结局指标

主要结局

Precise estimate of the local incidence and clinical/functional impact of PMPS

时间窗: 4 months

Hypothesized to result from damage to major peripheral nerves during surgery. The International Association for the Study of Pain (IASP) defines PMPS as persistent pain soon after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. The primary outcome will be the local incidence of PMPS at 4 months follow-up after surgery.

次要结局

  • Identify risk factors of PMPS(4 months)
  • Describe factors likely to prevent or reduce the development of PMPS after breast cancer surgery(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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