Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Psychological resiliency measured by Connor Davidson Resiliency Scale
研究概览
简要总结
This pilot clinical trial studies quality of life and supportive care preferences following radiation therapy in prostate cancer survivors. Studying quality of life and supportive care preferences in patients undergoing radiation therapy may help identify the effects of treatment on patients with prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To develop an understanding of the impacts of prostate cancer on aspects of psychological stress, physiological stress and health related quality of life (HRQL) for men who are being treated with some level of radiation therapy (RT).
II. To gain insight into the perceived needs of survivors depending on their disease stage, treatment regimen and side effects.
SECONDARY OBJECTIVES:
I. To explore whether biomarkers of stress, inflammation and autonomic control (heart rate variability [HRV]) can confirm or dispel the self-reported measures of psychological distress and HRQL of a unique population of aging men with prostate cancer.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Diagnosis of prostate cancer
- •Treatment with primary radiation (brachytherapy or external beam therapy), radiation + androgen deprivation therapy (ADT) or salvage prostatectomy
- •Body mass index (BMI) (26 - 40 kg/m^2)
- •Treating oncologist consent
- •Ambulatory or able to engage in walking for at least 45 minutes per intervention visit
- •Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week
排除标准
- •Poor diagnosis or other cancer
- •Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension
- •Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
- •Non-ambulatory
- •Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
- •Major mental illness (e.g., schizophrenia, major depressive disorder)
- •Unwilling to give consent
结局指标
主要结局
Psychological resiliency measured by Connor Davidson Resiliency Scale
时间窗: Baseline
The relationship with self-reported measures of quality of life and stress will be determined. Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Explore whether heart rate variability is associated with the SF-36 and Connor Davidson Resiliency Scale.
时间窗: Up to 1 week
Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
Develop an understanding of the impacts of prostate cancer on HRQL measured by the SF-36
时间窗: Baseline
Significance tests for the difference between treatment groups on all primary outcomes will be conducted. Data will be individually standardized by covariates such as age, disease stage and grade, time on treatment values and will be evaluated using an analysis of co-variance statistical mode. Descriptive statistics for the feasibility measures will be calculated prospectively throughout the trial.
次要结局
未报告次要终点
研究者
Brian Focht
Principal Investigator
Ohio State University Comprehensive Cancer Center