The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 444
- 主要终点
- Change in shoulder rotation flexibility
研究概览
简要总结
The present study evaluates the effect of yoga therapy on scarring contractures and shoulder joint motion and range in women diagnosed with breast cancer. A single-blinded prospective, randomized controlled trial will be used.
详细描述
To conduct a study to evaluate the effect of yoga therapy on scarring contractures and shoulder joint motion and range in women diagnosed with breast cancer using a single-blinded prospective, randomized controlled trial.
The aims are to test:
- To evaluate the impact of yoga therapy on scarring contractures and range of motion in shoulder joints among women recovering from surgical treatment of breast cancer.
- To evaluate the impact of yoga therapy on health-related quality of life and symptom distress.
Primary Hypotheses
- Intervention and control groups mean scores on measures of shoulder movement range will show no differences at baseline or significant changes at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
- Mean scores of quality of life and symptom distress between intervention and control groups at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention will show no differences relative to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant and inform them the allocation result.
The participants are masked in terms of not knowing that the yoga therapy is hypothesized to yield larger effects than the others.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cantonese-speaking Chinese patients
- •were newly diagnosed with breast cancer
- •had completed breast cancer surgery plus chemotherapy
- •were able to give consent
排除标准
- •Patients who have residual breast tumors or loco-regional metastasis after treatment
- •who were practicing yoga since the diagnosis of breast cancer
- •or are otherwise physically unable to yoga
结局指标
主要结局
Change in shoulder rotation flexibility
时间窗: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Start by holding a strap in front of the body with both hands wide apart and palms facing downwards. Lift the strap over the head to behind the back, maintaining the hand grip on the object. This movement must be made with extended arms. Repeat the movement, moving hands closer together each time until the movement cannot be completed with straight arms. To assess the flexibility, the best score of three trials is recorded. The score is the angle of fanning out, in degrees, calculated with the formula S/2L, where S = how much the sliding handle shifted in cm during the movement; L = length of arm in cm from acromion to the metacarpophalangeal joint of the middle finger.
Change in shoulder range of motion
时间窗: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Back scratch test. This test is performed in the standing position. Place one hand behind the head and back over the shoulder, then reach as far as possible down the middle of the back, with the palm touching the body and the fingers directed downwards. Place the other arm behind the back, palm facing outward and fingers upward and reach up as far as possible attempting to touch or overlap the middle fingers of both hands. To assess the range of motion, measure the distance between the tips of the middle fingers. If the fingertips touch then the score is zero. If they do not touch, measure the distance between the finger tips (i.e. a negative score). If they overlap, measure by how much (i.e. a positive score). Take two measures and use the best score.
次要结局
- Change in the severity of pain(Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.)
- Change in generic quality of life(Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.)
- Change in psychological distress(Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.)
- Change in sleep quality(Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.)
- Change in quality of life (Breast cancer specific)(Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.)
- Change in fatigue(Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.)
研究者
Wendy Wing Tak Lam
Associate professor
The University of Hong Kong