Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Intra-class correlation coefficients (ICC) for intra-rater reliability of self-measured arm circumference
研究概览
简要总结
Early detection and treatment of onset or worsening of breast cancer-related lymphedema (BCRL) can potentially prevent or postpone the condition to progress into a chronic progressive condition or eliminate the risk of infections in the arm (cellulitis). Self-surveillance for BCRL by routinely measuring own arm circumference could potentially enable early detection of onset or worsening of lymphedema. The aim is to determine whether women who have received surgery for breast cancer, can perform self-measures of arm circumference in a reliable and valid manner using written and video supported instructions without in-person teaching by a physiotherapist.
详细描述
Purpose: to test the reliability and validity of self-measured arm circumference compared to measures performed by a specialized therapist and by the perometer (gold standard).
The hypothesis is that there will be an excellent correlation between arm circumference measures performed by the participant and by an experienced physiotherapist and a moderate correlation between arm circumference measures performed by the patient and determined by perometer, as well as arm volume calculated from arm circumference measurements and measured by the perometer.
Design: A cross-sectional study of women at risk of breast cancer-related lymphedema (BCRL) (n=20) and with BCRL (n=20)
Procedures: Participants will complete one self-assessment at home and one self-assessment at a laboratory the University of British Columbia (UBC).
Home Self-assessment: Participants will be sent a study package by mail, which will contain the consent form, a tape measure, written instructions supplemented with illustrations, a link for a video guide, and a measurement form, along with an opaque envelop for the measurement form. Participants will be asked to first review the written and video material outlining the measurement process, prior to completing a short self-assessment quiz on the self-measurement technique. Participants will then perform arm circumference measures of both arms as per the instructions, record the measurements on the provided form and seal the form in a provided envelope. The envelope will be returned to the study team at the lab assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women, who have received surgery for breast cancer with axillary or sentinel lymph node dissection within the last 3 months to 5 years, including those who are undergoing chemotherapy or radiation
- •with and without a clinical diagnosis of BCRL in one or two arms
- •age 18 to 80 years
- •who can understand the self-measurement instructions given in English
- •who have access and ability to use internet to view the self-measurement video tutorial
排除标准
- 未提供
研究组 & 干预措施
Women with breast cancer-related lymphedema
Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.
干预措施: Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference (Procedure)
Women at risk of breast cancer-related lymphedema
Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.
干预措施: Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference (Procedure)
结局指标
主要结局
Intra-class correlation coefficients (ICC) for intra-rater reliability of self-measured arm circumference
时间窗: Self-measures performed twice with 2 days apart
ICC is scored from 0 to 1. Reliability is considered poor when the ICC \< 0.40, moderate between 0.40 and 0.75, substantial between 0.75 and 0.90, and excellent when \>0.90. The total agreement between self-measured arm circumference performed twice by the participant will be calculated.
Intra-class correlation coefficients (ICC) for inter-rater reliability between arm circumference measures performed by the participant herself and by the therapist.
时间窗: Both measures are performed same day within one hour
The total agreement between self-measured arm circumference performed by the participant and by a physiotherapist will be calculated.
Intra-class correlation coefficients (ICC) for concurrent validity of self-measured arm circumference and perometer-measures
时间窗: Both measures are performed same day within one hour
The total agreement between self-measured arm circumference performed by the participant and by a perometer will be calculated.
次要结局
未报告次要终点
研究者
Kristin Campbell
Associate Professor
University of British Columbia