跳至主要内容
临床试验/NCT01521741
NCT01521741招募中不适用

Prospective Screening for Breast Cancer-related Lymphedema: Analysis of Objective Measurements, Symptoms, Functionality, and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2009年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Upper extremity changes following treatment for breast cancer

研究概览

简要总结

The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.

详细描述

The goal of the study is to create a large, prospectively maintained database with data from multiple objective measurement methods (i.e. perometry and BIS) that has detailed information on patient's symptoms and quality of life measures that can be used to answer research questions.

The study design is prospective in nature, and a questionnaire will be utilized in conjunction with objective measurements before, throughout, and after a patient's treatment for breast cancer. This protocol is designed to mimic the current standard of care screening program with the addition of the quality of life questionnaire and BIS measurements.

Data collection will include medical chart review, perometric arm volume measurements, BIS measurements, and a subjective questionnaire. At their preoperative multidisciplinary breast cancer clinic appointment, patients will undergo baseline arm volume measurements per standard of care. At this time, eligible patients will be offered this study. Those who consent will be given a baseline questionnaire to fill out and have baseline BIS measurements taken. Throughout their treatment and follow-up, patients will periodically have BCRL screening every 2-12 months depending on their risk (i.e. patients who are high risk for BCRL because of extensive lymph node surgery will be measured more often than patients who did not have lymph nodes removed). These screening visits will coincide with naturally occurring oncology follow-up visits; although, patients are also screened when patient or provider requests and questionnaires/BIS measurements will be offered at these time points as well.

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
Female
接受健康志愿者

入选标准

  • Confirmed diagnosis of breast cancer
  • Ability to obtain physical positioning for perometry (e.g. abducting shoulder to 90 degrees) and BIS measurements (e.g. standing without aid)

排除标准

  • Evidence of distant metastatic disease that may cause edema,
  • Previous breast cancer
  • History of lymphedema
  • Pregnancy at the time of accrual and/or cardiac implants (contraindications for BIS)
  • Medical conditions that cause fluid retention or swelling (e.g. axillary cancer recurrence, renal insufficiency, congestive heart failure).

结局指标

主要结局

Upper extremity changes following treatment for breast cancer

时间窗: 1.5 to 5 years

During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities. The subject responses to the patient-reported outcome measures (BCLE-SEI questionnaire) obtained throughout their breast cancer treatment process will be analyzed in conjunction with arm volume measurements taken with both perometry and bioimpedance spectroscopy. This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.

次要结局

未报告次要终点

研究者

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

Alphonse Taghian

Chief of Breast Service

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验

Prospective Screening for Breast Cancer-related... | 临床试验