Estimating the minimal clinically important difference of thesix minutes walk distance in patients with breast cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)To estimate the minimally clinical important difference (MCID) of six minute walk distance (6MWD) in patients with Breast Cancer using Anchor and Distribution based methods.
研究概览
简要总结
The study protocol will be submitted to the Scientific and Institutional Ethics Committee, KMC Mangalore and upon approval, patients diagnosed with Breast Cancer and scheduled for Chemotherapy would be screened for inclusion and exclusion criteria. Patients fulfilling the inclusion criteria would be explained about the study and the willing participants would be asked to sign a written consent. Demographic data of the participants will be collected and written by the investigator.
Participants would undergo 6MWT at baseline (pretreatment) and after 16 weeks. The quality of life over the past week will be assessed by the EORTC QLQ-C30 at baseline and after 16 weeks and will be graded by the Likert scale.
Based on the anchor (Using the physical domain changes in questionnaire) and distribution (standard error, effect size of 6MWD based methods, statistically using (Boot strap) the MCID of 6MWD in patients with Breast Cancer will be calculated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with Breast Cancer stage II–III scheduled for curative intent chemotherapy treatment.
- •2.ECOG (Eastern Cooperative Oncology Group) performance status <2 3.Age 18years of age.
排除标准
- •1.Any musculoskeletal problems (e.g. knee pain, ankle pain) 2.Comorbidities limiting the 6MWT field testing (eg: cardiac arrhythmias, acute myocardial infarction, angina pectoris, patients with LVEF < 40 %).
结局指标
主要结局
1)To estimate the minimally clinical important difference (MCID) of six minute walk distance (6MWD) in patients with Breast Cancer using Anchor and Distribution based methods.
时间窗: Baseline and 16 weeks.
2)To evaluate the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at baseline (pretreatment) and after 16 weeks and to correlate physical domain of the questionnaire with Six minute walk distance (6MWD).
时间窗: Baseline and 16 weeks.
次要结局
未报告次要终点