Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Pose Modifications
研究概览
简要总结
This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of a modified yoga program for breast cancer survivors (BCS) with lymphedema.
II. To identify and document required modifications for a safe and feasible practice.
III. To obtain recruitment estimates and determine barriers to recruitment (acceptability).
IV. To evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Lymphedema Group:
- •Lymphedema, symptomatic of stage II or III based upon screening responses; or L-Dex reading of ≥ 7 at initial visit,
- •> 3 months (mths) post-breast cancer treatment
- •No active cancer
- •Has compression sleeve
- •Ability to understand English in order to complete questionnaires
- •Willing to do guided and home yoga practice
- •Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
- •Medical clearance
- •Reliable transportation to the study site
- •No Lymphedema Group:
- •No known lymphedema or intermittent swelling, not symptomatic of Stage II or III lymphedema (L-Dex ≥ 7)
- •>3 months post- breast cancer treatment
- •No active cancer
- •Ability to understand English in order to complete questionnaires
- •Willing to do guided and home Yoga practice
- •Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
- •Medical clearance
- •Reliable transportation to the study site.
- •Exclusion Criteria (Both Groups):
- •Active cancer
- •Undergoing radiation therapy or chemotherapy
- •Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status)
- •Active yoga practice < 3 months
- •Currently undergoing phase I complete decongestive therapy (CDT)
- •Inability to complete study forms
排除标准
- 未提供
研究组 & 干预措施
Supportive Care (Yoga)
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made.
干预措施: Yoga (Procedure)
Supportive Care (Yoga)
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made.
干预措施: tape measurement of arm (Other)
Supportive Care (Yoga)
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (Yoga)
Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made.
干预措施: ldex measurement of arms (Other)
结局指标
主要结局
Pose Modifications
时间窗: Up to 8 weeks
number of poses requiring modifications as indicated in the modification form
Assess safety
时间窗: Up to 8 weeks
Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0
次要结局
未报告次要终点
研究者
Sheila Ridner
Principal Investigator
Vanderbilt-Ingram Cancer Center