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临床试验/NCT00027118
NCT00027118已完成不适用

A Prospective (Cohort) Study to Identify Factors Affecting Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center (BCC)

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2001年11月16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
326
试验地点
1
主要终点
Quality of life questionnaire

研究概览

简要总结

This study will examine the frequency and severity of problems in women with breast cancer for 2 years following initial medical treatment, including:

  • Physical impairments, such as loss of strength or flexibility, increased weight and swelling.
  • Symptom distress, such as pain, fatigue and weakness.
  • Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities.

It will identify factors associated with these problems and try to determine their relationship to them.

Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Women who have a breast biopsy negative for cancer will also be enrolled as control subjects. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2001-2003.

Participants will be evaluated over a 2-year period during an initial baseline visit (before medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following procedures:

  • Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.
  • Completion of questionnaires including health survey, upper limb disability questionnaire, and physical activity questionnaire. (Questionnaires are completed only at baseline and 12 and 24 months after medical treatment begins.) The questionnaires take about 30 to 40 minutes to complete.
  • Upper body examination, including pain measurement using a 10-point scale, active and passive range of motion measures, manual muscle testing measures using a 10-point scale, timed upper limb lift test, and measures of upper limb volume and girth.

详细描述

Patients and healthy participants will undergo an interview at the beginning of the study and 1,3,6,9, 12, 18 and 24 months and answer questions about their medical history; family history; current problem and treatment; pain history; and social, physical and recreational activities. At the visit, they will also undergo an upper body physical exam by a physical therapist. Patients and the healthy participants will also fill out questionnaires about arm disability, quality of life, and physical activity at the beginning of the study and at 12, 18, and 24 months.

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 85 Years(Adult, Older Adult)
性别
All
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

Quality of life questionnaire

时间窗: 0, 12, 18, 24 months

Upper limb strength

时间窗: 1,3,6,9, 12, 18 24 months

Upper limb volume

时间窗: 1,3,6,9, 12, 18 24 months

Upper limb range of motion

时间窗: 1,3,6,9, 12, 18 24 months

Arm disability questionnaire

时间窗: 0, 12, 18, 24 months

Physical activity questionnaire

时间窗: 0, 12, 18, 24 months

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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