Effectiveness of Exercise Training and Self Management in the Attenuation of Anxiety and Depressive Symptoms Following Breast Biopsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Symptoms of anxiety will be assessed using patient reported anxiety inventory
研究概览
简要总结
The breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. Physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. This study aims to determine if a pre treatment exercise intervention can minimize symptoms of anxiety and depression in women undergoing screening for breast cancer.
详细描述
The breast cancer diagnostic process is associated with anxiety and depression. Physical exercise has emerged as an attractive non-pharmacologic approach to mitigating the psychological and physical sequelae of breast cancer and its treatments, however pre treatment interventions are not integrated into current practice. This study aims to determine the effectiveness and feasibility of a pre treatment exercise intervention in attenuating levels of anxiety and depression following breast biopsy and throughout the diagnostic period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •undergoing breast biopsy at St. Joseph's Health Care, London Ontario
- •minimum BI-RADS 4a
- •physically inactive
排除标准
- •meeting Health Canada Guidelines for Physical Activity for past 6 months
- •medical contraindications to exercise
- •unable to participate in moderate intensity exercise program
结局指标
主要结局
Symptoms of anxiety will be assessed using patient reported anxiety inventory
时间窗: Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6
Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, \& Lushene, 1970).
次要结局
- Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory(Within 1 week of breast biopsy)
- Exercise behaviour will be assessed using a patient reported inventory(Within 1 week of breast biopsy, Week 3, Week 6)
- Self Efficacy: patient reported inventory assessing efficacy for self management of exercise(1 week post breast biopsy, Week 3, Week 6)
- Optimism: patient reported inventory assessing dispositional optimism(Baseline (within 1 week of core breast biopsy))
- Symptoms of subclinical depression will be assessed using a patient reported inventory(Within 1 week of breast biopsy, Week 3, Week 6)
- Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)(Baseline (within 1 week of breast biopsy), Week 6)