The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of conducting a larger randomized trial using yoga and mindful movement
研究概览
简要总结
The investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. The investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life compared to women not participating in the program. The investigators predict that this will be associated with decreased markers of inflammation. The investigators will also evaluate whether there is improved pathologic response rate compared to historical controls. This study will provide pilot data for a larger randomized controlled trial assessing whether program can provide long-term improvement in quality of life, weight maintenance, and the serum and tumor changes correlating with a reduced risk of recurrence and mortality.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Yoga
- Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
- Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
- The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
- During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
干预措施: Yoga (Other)
Arm 1: Yoga
- Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
- Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
- The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
- During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
干预措施: Blood draw (Procedure)
Arm 1: Yoga
- Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
- Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
- The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
- During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
干预措施: FACT-G questionnaire (Behavioral)
Arm 1: Yoga
- Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
- Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
- The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
- During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
干预措施: Weight measurement (Procedure)
Arm 1: Yoga
- Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
- Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
- The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
- During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
干预措施: Recent Physical Activity Questionnaire (Behavioral)
Arm 1: Yoga
- Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
- Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
- The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
- During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
干预措施: NHANES Food Questionnaire (Behavioral)
Arm 2: No Yoga
-Patients in this arm will not receive a personalized yoga plan
干预措施: Blood draw (Procedure)
Arm 2: No Yoga
-Patients in this arm will not receive a personalized yoga plan
干预措施: FACT-G questionnaire (Behavioral)
Arm 2: No Yoga
-Patients in this arm will not receive a personalized yoga plan
干预措施: Weight measurement (Procedure)
Arm 2: No Yoga
-Patients in this arm will not receive a personalized yoga plan
干预措施: Recent Physical Activity Questionnaire (Behavioral)
Arm 2: No Yoga
-Patients in this arm will not receive a personalized yoga plan
干预措施: NHANES Food Questionnaire (Behavioral)
结局指标
主要结局
Feasibility of conducting a larger randomized trial using yoga and mindful movement
时间窗: Completion of study enrollment (estimated to be 6 months)
-Feasibility is defined as the ability to have an 80% completion rate of the intervention
Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled
时间窗: Completion of study enrollment (estimated to be 6 months)
-Feasibility is defined as the ability to enroll 60% of eligible patients
Efficacy of yoga exercise as measured by weight change from baseline to completion
时间窗: Completion of treatment (estimated to be 6 months)
次要结局
- Effect of yoga exercise as measured by inflammatory markers(Completion of treatment (estimated to be 6 months))
- Effect of yoga exercise as measured by quality of life(Completion of treatment (estimated to be 6 months))
- Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)(Completion of treatment (estimated to be 6 months))
- Effect of yoga exercise as measured by fatigue index(Completion of treatment (estimated to be 6 months))