Effects of Qigong on Fatigue & Quality of Life in Elderly Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Retention Rate in Study (Feasibility Outcome)
研究概览
简要总结
Aim 1: Assess the feasibility, safety and efficacy of a Qigong intervention in elderly prostate cancer survivors.
Describe participation, retention, and adherence rates and assess reasons for participation, attrition, and non-adherence.
Identify effective recruitment and retention strategies. Ascertain participants' level of satisfaction and additional perceptions of the experimental and control interventions, perceived study burden, study design, and implementation.
Aim 2: Provide preliminary data on potential effects of Qigong vs. non-aerobic stretching exercises on fatigue, psychosocial outcomes, and health-related quality of life in preparation for a future R01 application for a larger, definitive randomized controlled trial. Hypothesis: Qigong participants will have improved fatigue levels, quality of life, and related psychosocial and health outcomes compared to those randomized to the non-aerobic stretching group.
详细描述
This ongoing feasibility study is a two-armed, parallel group, randomized clinical trial.We will recruit 60 elderly prostate cancer survivors (age 55+ years) and their significant others (spouse, domestic partner, or close family member).
Considering literature attesting to strains associated with caregiver status, we will also collect survey and physical assessment data to explore the intervention's effect on significant others.
Recruitment occurs through Huntsman Cancer Institute's outpatient clinic and University and community-based strategies (for example, newspaper ads, flyers, support groups, patient registries).
We will measure relevant psychosocial measures, including fatigue and quality of life (SF36 & EPIC), perceived stress, distress, mood, cognitive function, social connectedness, demographics, and leisure time, at baseline, the six-week midpoint, and one week post-intervention. Weekly measures of fatigue and quality of life and physical activity logs will also be administered.
Biometric assessments, including balance and mobility, flexibility, blood pressure, resting heart rate, body mass index, and waist-hip-ratio, will be done at baseline (before randomization) and one week post-intervention.
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
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant fatigue as assessed during screening with the NCI Common Terminology Criteria for Adverse Events (CTCAE) Safety Profiler of fatigue using a cut-off value of ≥ 1; and/or with a fatigue grading scale (general questions that assess level of fatigue currently and in the past week from a scale of 0-100) with a cut off value of >20
- •Are sedentary as defined by <150 minutes of mild, moderate, or intense intensity exercise/week per Centers for Disease Control and Prevention(CDC) guidelines
- •Able to speak and read English fluently, and understand informed consent
- •Reside within 60 miles of Huntsman Cancer Institute and have access to regular transportation to all assessments and intervention classes at HCI
- •Willing to: sign a medical record release form; be randomized and willing to participate in classes and all baseline and follow-up appointments
- •Significant others and domestic partners of elderly prostate cancer survivors will be eligible if they are at least 18 years of age, read and speak English, willing to sign an informed consent, and provide a physician's release for exercise
排除标准
- •Clinical evidence of metastatic disease other than elevated prostate-antigen specific (PSA) levels
- •Current practice of Qigong, Tai Chi or other similar types of Complementary and Alternative medicine that may share similar principles of Qigong
- •Inability to pass the Folstein Mini Mental Status Exam (score <23)
- •Unable to drive or secure transportation to complete all aspects of the study
- •Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention
- •Unwilling to be randomized to study groups and/or commit to 12 weeks of Qigong or non-aerobic stretching classes
结局指标
主要结局
Retention Rate in Study (Feasibility Outcome)
时间窗: 13-weeks
The retention rate was the proportion of participants who remained enrolled in the study and completed post-intervention measures. Range of retention rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).
FACIT-Fatigue Change From Baseline to 13-weeks.
时间窗: Baseline to 13-weeks
Our primary outcome of change in fatigue was assessed with the Functional Assessment Chronic Illness Therapy (FACIT)-Fatigue scale. This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.
Attendance Rates in Study (Feasibility Outcome)
时间窗: 13-weeks
The class attendance rates were the number of classes attended by participants divided by the total number of classes offered. Range of attendance rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).
次要结局
- Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks(Baseline to 13-weeks)
研究者
Anita Kinney
Jon & Karen Huntsman Presidential Professor in Cancer Research
University of Utah