Effect of Psychological, Nutritional and Activity Support Physical on Recovery After Treatment by Prostatectomy for Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Comparison of changes (over time) in quality of life for control and study groups
研究概览
简要总结
This is a pilot, prostective, comparative, randomized, monocentric open-label study whose main objective is to determine whether appropriate psychological, nutritional and physical activity support can improve the quality of life of carrier patients. localized prostate cancer treated by prostatectomy
详细描述
Pilot study to demonstrate the benefits of a multimodal intervention (psychological and nutritional support and physical activity) on the recovery of patients treated by prostatectomy for localized prostate cancer.
After inclusion of 100 patients, at week 6 will undergo a prostatectomy and then at week 9 will be randomized into two groups of 50 patients for each group.
Groupe Intervention which will benefit from multidisciplinary care over 12 weeks (one APA session per week plus 5 workshops with the psychologist and a workshop with the dietician) plus a visit with the urologist.
Then after 3 months, 6 months and 12 months, the group benefit from an evaluation with the urologist, the teacher of adapted physical activity and the dietitian.
-For the control group, it will be followed classically, a visit to the urologist, an assessment with the teacher of physical activity and the dietician, after prostatectomy, then at 3 months, 6 months and at 12 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 72 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •WHO score 0 or 1
- •Adult patients with localized prostate cancer eligible for surgical treatment according to the AFU criteria following the CAPRA and d'Amico classifications: low risk or risk intermediaries. These are patients under the age of 73, with clinical stage and or MRI < or = T3, PSA < or = 20 ng/ml, with assessment negative extension (bone scintigraphy, thoraco-abdomino-pelvic scanner, Choline Pet-scanner)
- •Informed and written consent signed by the patient
- •Person affiliated with social security or beneficiary of such a scheme
排除标准
- •WHO score greater than or equal to 2
- •MMSE score below 20
- •Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to a legal protective measure)
结局指标
主要结局
Comparison of changes (over time) in quality of life for control and study groups
时间窗: At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention
The program will focus on changes in quality of life. Quality of life will be measured using a questionnaire. Comparaison of changes in quality of life for control and study groups: Between patients treated with prostatectomy receiving either a standard or a multimodal therapy. At several time points during the study period, from baseline assessments(T0) up to follow up:3,6 and 12 months after start of intervention, using the Functional Assessments of Cancer Therapy-Prostate (FACT-P) questionnaire. With higher score correlating with better quality of life. Adapted Physics) at 3, 6, and 12 months will be studied using a model linear mixed
次要结局
- Assessing physical performance(After surgery up to follow up: at 3, 6 and 12 months)
- The quality of physical activity(At baseline, 3 weeks after prostatectomy, 3, 6 and 12 months after start of intervention)
- Cardiorespiratory fitness assessment(From baseline assessments up to 3 weeks after prostatectomy)
- Well-being assessment(From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention)
- Physical performance (quadriceps and biceps endurance tests)(From baseline assessments up to 3 weeks after surgery)
- Emotional regulation assessment(3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention)
- Anxiety assessment-Self reported anxiety level(From 3 weeks after prostatectomy up to follow up: 3, 6 and 12 months after start of intervention)
- Psychological distress (in terms of depression and anxiety) assessment(From 3 weeks after prostatectomy up to follow up:3, 6 and 12 months after start of intervention)
- Nutritional assessment/Nutrition-related variables(After prostatectomy up to follow up)
- Patient adherence to nutritional care and support(From 3 weeks after prostatectomy up to 3 months after start of intervention and in the empowerment process at 6 and 12 months)
- Physical Activity commitment(Patient adherence will be measured each month during the entire study.)