A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- intervention acceptability
研究概览
简要总结
A randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the feasibility and acceptability of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.
详细描述
This is a PI-initiated, randomized, unblinded, clinical trial of a technology-based 3 month lifestyle intervention vs. usual care among men with low risk prostate cancer. We will recruit and consent 76 men with prostate cancer at UCSF. The subjects will be asked to complete questionnaires, 7 days accelerometer measurement, body measurements (weight, waist, hip, pulse, blood pressure) and collection of blood specimen at baseline and 3 months. Subjects will be randomized into two arms (Intervention Group and Control Group). The Intervention Group (N=38) will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive text messages, and be provided with individualized lifestyle recommendations. The Control Group (N=38) will have standard of care and be asked to continue with their usual lifestyle habits. They will receive access to the lifestyle website and be provided with individualized lifestyle recommendations at 3 months.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •clinical stage ≤T3a nonmetastatic prostate cancer within 5 years
- •completion of treatment ≥3 months prior to enrollment, if not on active surveillance
- •ability to walk unassisted
- •be able to speak and read English
- •ability to navigate websites and email, and have internet access
- •able to travel to UCSF for pre- and post-study blood collection
排除标准
- •any contraindications to moderate or vigorous aerobic exercise
- •psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol
- •reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening
研究组 & 干预措施
Group 1- Lifestyle Intervention
Men will receive a web-based, personalized lifestyle program. They will receive personalized prostate cancer-specific lifestyle recommendations on specific habits based on their eligibility survey responses. They will have access to the website composed of four topic areas (get active, eat well, stop smoking, and find support), receive a Fitbit and access to a Fitbit account and community group, and receive text messages and refrigerator magnet to reinforce behaviors. The website will be updated frequently with new tips and material and two weekly blogs will be maintained. Final content is reviewed by study investigators and patient advocates. Men will complete an intervention acceptability survey (acceptability of the website and intervention components) at 3 months.
干预措施: Lifestyle intervention (Behavioral)
Group 2 - Control
Men randomized to the control group will receive standard of care. They will receive access to the website and personalized lifestyle recommendations on the 8 healthy habits targeted in the study after the 3 month trial.
结局指标
主要结局
intervention acceptability
时间窗: 3 months
We will assess intervention acceptability via questionnaire at 3 months in the intervention group.
website use - number of days the website was visited
时间窗: 3 months
We will measure the total number of days the website was visited in the intervention arm only during the study period to assess study feasibility
Fitbit use
时间窗: 3 months
We will measure the number of days the Fitbit was used during the study period in the intervention arm only to assess study feasibility
website use - number of website visits
时间窗: 3 months
We will measure the total number of website visits in the intervention arm only during the study period to assess study feasibility
text message use
时间窗: 3 months
We will measure the number of text messages responded to that required a reply in the intervention arm only during the study period to assess study feasibility
self-reported change in health behaviors
时间窗: 3 months
We will assess change in health behaviors via questionnaire at baseline and 3 months.
次要结局
- maintenance or adoption of self-reported behaviors after 1 year(1 year)
- change in fasting glucose(3 months)
- change in physical activity measured by activity monitor(3 months)
- change in task self-efficacy(3 months)
- change in plasma antioxidant lycopene(3 months)
- change in cholesterol(3 months)
- change in waist circumference(3 months)
- health-related quality of life(3 months)
- change in plasma antioxidant Vitamin E(3 months)
- change in weight(3 months)
- change in body mass index(3 months)
- anxiety(3 months)
- change in hemoglobin A1c(3 months)
- change in C-reactive protein(3 months)
- depression(3 months)