Prehabilitation in Prostate Cancer Patients Undergoing Nerve Sparring Robot Assisted Radical Prostatectomy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Localized prostate cancer is commonly treated with radical prostatectomy (RP). Following surgery adverse effects such as urinary incontinence, erectile dysfunction associated with decreased quality of life and decreased physical function are common.
Traditionally, interventions to reduce these adverse effects are introduced postoperatively. However, a growing body of literature shows the benefit of interventions prior to surgery to enhance treatment success, known as prehabilitation.
Hence, the main purpose of this study is to develop and investigate the feasibility of prehabilitation using telehealth, to implement several interventions prior to elective RP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Male > 18 years
- •Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP
- •Adequacy in written and spoken Danish
- •Cognitively well-functioning
- •Able to understand the study procedures and willing to provide signed informed consent
排除标准
- •Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders.
- •No possibility to use a smartphone or tablet.
结局指标
主要结局
Recruitment rate
时间窗: 12 months
Percentage of eligible patients who accepted to participate in the study. Recruitment rate is measured by dividing the number of patients consented by the number of patients screened.
Protocol adherence, assessed by study-specific questionnaire
时间窗: 12 months
The pt. will every week register his adherence to the intervention protocol. The number of intervention components which were not fulfilled during the prehabilitation period will be counted, and the percentage of deviation will be calculated compared to the total number of intervention components.
Number of participants who received the nutritional and mental health intervention.
时间窗: 12 months
Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.
Retention rate
时间窗: 12 months
Percentage of participants completing the full prehabilitation period, and full follow-up after the surgery. Retention rate is measured by dividing the number of patients completing the study with the number of patients consented.
次要结局
- Grip strength test(12 months)
- Self-reported physical activity(12 months)
- Hospital Anxiety and Depression Scale (HADS)(12 months)
- 5-Item International Index of Erectile Function (IIEF-5)(12 months)
- Nutritional Risk Screening(At baseline (4 weeks before the surgery).)
- 6-minute-walk-test (6MWT)(12 months)
- 30 seconds sit-to-stand test (30STS)(12 months)
- 24-hour Pad Weigh Test(6, 24 and 50 weeks post surgery.)
- 12-Item short form Health Survey (SF-12)(12 months)