Energy Balance for Prostate Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in body weight during the post-surgical period
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.
详细描述
The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:
- Diet
- Physical activity
- Coaching
- Diet and exercise monitoring tool
The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 72 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
- •Body Mass Index (BMI) 25-45 kg/m2
- •Have internet access
- •Have an iPad/iPhone/iDevice
排除标准
- •History of 5 alpha reductase inhibitors prior 3 months
- •History of radiation therapy
- •Taking active cancer treatment
- •Undergoing salvage therapy
- •Castration-resistant prostate cancer
- •Evidence of metastasis
- •Evidence of biochemical recurrence
- •High risk medical condition (e.g. gout or kidney disease)
研究组 & 干预措施
Weight loss intervention Group
Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.
干预措施: Weight Loss Program (Other)
Comparison Group
All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in body weight during the post-surgical period
时间窗: Change from Surgery to Week 20
次要结局
- Prostate cancer status(Week 20)
- Changes in body weight during the pre-surgical weight-loss intervention(Change from Baseline to Week 8)
- Changes in diet quality during the pre-surgical weight-loss intervention(Change from Baseline to Week 8)
- Change in cardiovascular biomarkers(Change from Baseline to Week 20)
研究者
Jill Hamilton-Reeves, PhD RD LD
Assistant Professor
University of Kansas Medical Center