NCT00994279已完成不适用
Yoga or Wellness Education During Breast Cancer Treatment: Establishing Community-Based Partnerships
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga is more effective than wellness education for women with breast cancer who are undergoing chemotherapy.
PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how well it works compared with an educational wellness class for women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.
详细描述
OBJECTIVES:
Primary
- To estimate the participation rate, accrual, adherence, and retention to a community-based study of yoga vs an active control (wellness education) in women with stage I-III breast cancer undergoing chemotherapy.
Secondary
- To obtain estimates of the variability of women's self-reported fatigue and depressive symptoms, sleep quality, and health-related quality of life from baseline to the end of the intervention at 10 weeks.
- To obtain estimates of the efficacy of a community-based yoga intervention in women with breast cancer.
- To standardize the yoga protocol for use in multiple community settings with breast cancer patients, and ascertain that yoga teachers can adhere to a uniform protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Women will be eligible if they are:
- •Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start Yoga/Wellness sessions prior to second chemotherapy treatment.
- •≥18 years of age.
- •Physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ECOG Performance Status rating 0-2; Zubrod et al., 1960).
- •Diagnosed with breast cancer Stages I-III.
- •Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.
- •2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. Given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.
- •Are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or Herceptin therapy only (no chemotherapy).
- •Anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.
- •Have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.
- •Pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. The anticipated number of pregnant women eligible to enroll is minimal.
结局指标
主要结局
Retention
时间窗: 10 weeks
Proportion of participants completing the 10 week study
次要结局
- Fatigue at 10 Weeks(10 weeks)
研究者
研究点 (2)
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