Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total Practice Time as Assessed in Minutes Within the Study Application.
研究概览
简要总结
Cancer survivorship is associated with many long-term chronic health issues that arise as a result of cancer treatment protocols. Non-pharmacological lifestyle and mind-body interventions have been shown to be effective and critical components of a total-health strategy for cancer survivors. PranaScience Institute seeks to develop and test a novel group video app for home-based delivery of a Yogic Breathing intervention that reduces symptoms of cancer treatment survival and supports total-health.
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
- Single (Participant)
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
- •Age 18 years or older, willing to provide informed consent.
- •Diagnosis of Stage 0-III breast cancer.
- •Completion of radiation therapy within the last 6 months.
- •ECOG performance status of 0-3 during cancer treatment.
- •Orally expressed visual and auditory acuity adequate for filling out all study forms and participating in telephone interviews and internet-based group video applications.
- •Access to telephone and internet-connected computer or mobile phone.
排除标准
- •Subject is unwilling or unable to comply with any of the study procedures.
- •Orally expressed dependence on alcohol or drugs.
研究组 & 干预措施
Yoga Breathing (YB)
A first production version of a mobile application that guides users through proscribed yoga breathing exercises.
干预措施: Yoga Breathing (Behavioral)
Attention Control
A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Total Practice Time as Assessed in Minutes Within the Study Application.
时间窗: 12 weeks
Adherence will be evaluated by assessing total practice times by length in minutes.
Practice Frequency as a Measure of Adherence
时间窗: 12 weeks
Adherence is assessed by quantifying the number of completed app-based practice sessions relative to the total number of available sessions over 12 weeks. Each practice session is defined as a 10-minute, app-timed exercise, automatically logged in the mobile application's backend (including both individual and group sessions). Adherence is operationalized as: Practice Frequency = total number of completed sessions Practice Proportion = completed sessions ÷ total possible sessions (180 sessions maximum; 3 sessions/day × 5 days/week × 12 weeks). Both metrics are captured automatically by the app, which records each timed session as a completed practice. Higher values indicate greater adherence.
Participants' Symptom Management as Measured by the System Usability Scale.
时间窗: 12 weeks
Acceptability measures the participant's symptom management throughout the study duration. This is measured using The System Usability Scale (SUS) questionnaire, a 10 item questionnaire with 5 response options ranging from 'Strong Agree' to 'Strong Disagree'. The questionnaire will be administered at the end of 12 weeks to measure participants' acceptability of the study application. The acceptability is defined as a value of at least 68% in System Usability Scale. The values 0.6 and 0.2 represent 60% and 20% respectively. The higher percentage indicates greater system usability (meaning acceptability) of the app.
次要结局
- Change in Perceived Stress (Perceived Stress Scale-10)(12 weeks)
- Change in Depression Symptoms (Depression Scale)(12 weeks)
- Change in Symptom Burden (MD Anderson Symptom Inventory)(12 weeks)
研究者
Sundar Balasubramanian
Principal Investigator, Founder, Owner
PranaScience Institute LLC