Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Number of Awakenings After Sleep Onset
研究概览
简要总结
The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer.
详细描述
The primary objective of this study is to determine whether exposure to a website with recommendations about sleep and lifestyle for patients with prostate cancer and caregivers leads to an improvement in sleep and healthy lifestyle.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult U.S. male age >18 with prostate cancer OR
- •Adult U.S. male or female >18 who is a family member/partner/caregiver of a prostate cancer patient AND
- •Telephone and internet access AND
- •Able to read, comprehend, and sign informed consent in English AND
- •Perceived deficits in sleep, nutrition, and/or physical activity
排除标准
- •Age <18 years
- •Not English proficient
- •No or irregular access to the same telephone number and/or mailing address
- •No or less than weekly access to the internet
- •Patients who do not have a diagnosis of prostate cancer
- •Caregivers/family members for a condition other than prostate cancer
- •Mental or cognitive impairment that interferes with ability to provide informed consent
- •Surgery within the past 6 weeks or planned within the next 3 months (must wait until cleared to participate)
- •Other restrictions or upcoming events that affect sleep, physical activity or nutrition (e.g. doctor's orders)
结局指标
主要结局
Change in Number of Awakenings After Sleep Onset
时间窗: Baseline, 3 months
The study team will use ActiGraph software to calculate device-based measure number of awakenings (when a participant wakes up) after sleep onset (the transition from wakefulness into sleep).
Change in Sleep Hygiene Index (SHI) Score
时间窗: Baseline, 3 months
SHI is a 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
时间窗: Baseline, 3 months
PSQI contains 19 self-reported questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score "0" indicates no difficulty, while "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points; the higher the score, the more severe the difficulties in all areas.
Change in Sleep Efficiency
时间窗: Baseline, 3 months
The study team will use ActiGraph software to calculate device-based measures of sleep efficiency. Sleep efficiency is the ratio of total sleep time (total time spent asleep) to time in bed and is reported as a percentage (total sleep time / time in bed x 100).
Change in Insomnia Severity Index Score
时间窗: Baseline, 3 months
The Insomnia Severity Index has 7 questions, each rated on a 5-point Likert scale (0-4). The total score range is 0-28; the higher the score, the more severe the insomnia. 0-7 = no clinical significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinical insomnia (moderate severity), and 22-28 = clinical insomnia (severe)
Change in Sleep Duration
时间窗: Baseline, 3 months
The study team will use ActiGraph software to calculate device-based measures of sleep duration
次要结局
- Change in Dietary Consumption(Baseline, 3 months)
- Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day(Baseline, 3 months)
- Change in device-based step counts per day(Baseline, 3 months)
- Change in self-reported total physical activity MET-minutes per day(Baseline, 3 months)