Influence of Mind-Body Interventions on Cancer-Related Symptom Management in Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in quality of life
研究概览
简要总结
This clinical trial studies how well mind-body interventions work in improving quality of life (QOL), stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer. For many cancer survivors, the experience of cancer extends well beyond the completion of therapy. Common long-term effects include fatigue, cognitive impairment, anxiety, depression, sleep disturbance, and diminished physical function, all of which contribute to reduced QOL and overall health. Yoga, a mind-body intervention, utilizes breathwork, meditation, and gentle movement to help reduce activity in the body's nervous system. Breathwork and meditation have been shown to improve heart rate variability (a measure of the body's ability to adapt to stress). Movement-based practices may offer added benefit by supporting coordination and physical resiliency, aspects that are often reduced after cancer treatment and can lead to decreased QOL. This trial may help researchers determine whether a mind-body intervention that includes breathwork and meditation, as well as an intervention that includes breathwork and meditation plus gentle movement can work to improve QOL, stress, and sleep quality among survivors of breast, prostate, endometrial, or colorectal cancer.
详细描述
PRIMARY OBJECTIVE:
I. Pilot test video and/or audio content consisting of six, 15-minute breathwork and meditation videos/audio, and six, 15-minute guided, gentle movement videos developed for this intervention for feasibility and acceptability, and provide preliminary data on QOL in cancer (breast, colon, endometrial, and prostate) survivors using patient-reported outcomes measurements completed at pre- and post- intervention.
SECONDARY OBJECTIVES:
I. Evaluate program satisfaction using structured questionnaires for all participants at post-intervention.
II. Identify perceived barriers, evaluate facilitators, and identify recommendations for future scaling and delivery in varied survivorship settings
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
- All
- 接受健康志愿者
- 否
入选标准
- •Received a diagnosis of invasive, non-metastatic breast, colorectal, endometrial, or prostate cancer within the past 12 months
- •Have completed active anti-cancer therapy (hormonal, bisphosphonate, or androgen therapy is allowed)
- •Able to safely participate in light-weight physical activity (e.g. gentle yoga)
排除标准
- •Individuals with skeletal instabilities, cardio-pulmonary comorbidities, or other conditions that may preclude safe participation in light physical activity
- •Pregnant or nursing female participants
- •Unwilling or unable to follow protocol requirements
- •Any condition that, in the Investigator's opinion, deems the participant an unsuitable candidate
- •Unable to complete survey questionnaires in English
结局指标
主要结局
Change in quality of life
时间窗: Baseline up to 6 weeks
Patients view guided breathwork, meditation, and gentle yoga movement videos and complete these exercises over 30 minutes weekly for 6 weeks on study. Patients also wear an activity tracker throughout the study
次要结局
- Adherence Rate(UP to 6 weeks)
