The PANO Trial: Perioperative Exercise and Nutrition Optimisation Prehabilitation in Cancer Patients With Peritoneal Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Feasibility of intervention effectiveness
研究概览
简要总结
People who are diagnosed with cancer of the colon/rectum/appendix/ovaries that spreads into the lining of the tummy and some ovarian cancers or people with pseudomyxoma peritonei can often undergo intensive treatment including major surgery where chemotherapy is given whilst the person is having surgery - also known by doctors as surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Fitness for this surgery can improve if people undertake a prehabilitation programme at the time they get their diagnosis. To date, little research has focused on how exercise and nutrition support before surgery can help these patients during recovery. The aim of this study is to explore the use of exercise and nutritional support pre-treatment to enhance physical and psychological outcomes for patients.
详细描述
The comparator in this study will be standard oncological care. Control patients will receive the same care as standard without the addition of a formal exercise and nutrition support programme. The pre-treatment (prehabilitation) programme will commence following diagnosis and continue up to the point of surgery and recommence for six weeks following surgery when deemed clinically fit to participate. Assessments will occur at baseline, pre-surgery, post-surgery, and 6 weeks later and a follow up... Mixed methods will be employed with patients taking part in self-report assessments, physical assessments, and qualitative interviews. The primary aim of the study is to assess the feasibility of the intervention and cardiorespiratory fitness pre-surgery. The secondary aims include assessing the effect of the intervention on physical health, psychological wellbeing, health-related quality of life, self-efficacy, nutrition, and serology markers. Exploratory aims also include post-operative morbidity, health economics analysis and qualitative interview of patient experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
It will not be possible to be blinded to the to the allocation of participants due to their active involvement in the behavioural exercise and nutritional interventions during the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years,
- •multidisciplinary team referral for CRS-HIPEC for colorectal/appendix/ovarian peritoneal disease or pseudomyxoma peritonei (+/- completed neoadjuvant cancer treatment)
- •WHO performance status ≤2.
排除标准
- •inability to provide informed consent,
- •impaired cognitive function with a reduced ability to either understand advice /instructions from or communicate with the research team,
- •declined surgery,
- •surgery in less than 2 weeks
- •pregnancy or breastfeeding,
- •inability to participate in the exercise training (unable to perform the 6 Minute Walk Test)
- •absolute contraindications to exercise testing, veganism.
研究组 & 干预措施
Intervention
Exercise: The exercise training program was designed to improve physical fitness prior to surgery and for a 6-week period after surgery once deemed fit.
Nutrition: The nutritional arm consists of nutritional intervention tailored to the outcome of the nutritional screening.Participants will be asked to take part in a dietary food recall system called Foodbook24, and based on their dietary needs will be supported in nutritional optimisation.
干预措施: Exercise (Behavioral)
Intervention
Exercise: The exercise training program was designed to improve physical fitness prior to surgery and for a 6-week period after surgery once deemed fit.
Nutrition: The nutritional arm consists of nutritional intervention tailored to the outcome of the nutritional screening.Participants will be asked to take part in a dietary food recall system called Foodbook24, and based on their dietary needs will be supported in nutritional optimisation.
干预措施: Nutrition (Behavioral)
Control
This group will receive standard oncological care and will receive no formal education of exercise or nutritional intervention.
结局指标
主要结局
Feasibility of intervention effectiveness
时间窗: 2-6 weeks pre-surgery, 6 weeks post-surgery
Prehabilitation fidelity in terms of intervention effectiveness as measured by qualitative patient feedback at two timepoints. Monitoring of patient activity logs. Engagement with online and in-person exercise and nutritional intervention resources.
Feasibility of Adherence to the Intervention
时间窗: 2-6 weeks pre surgery, 6 weeks post-surgery
Prehabilitation fidelity in terms of the patient group adherence as measured by patient structured qualitative feedback and activity logs.
Feasibility of participant retention to the Intervention
时间窗: 2-6 weeks pre-surgery, 6 weeks post-surgery
Prehabilitation fidelity in terms of the patient group retention as measured by patient screening and retention logs and monitoring of recruitment rates.
Change in Cardiorespiratory Fitness
时间窗: 2-6 weeks pre-surgery, 6 weeks post-surgery
Cardiorespiratory fitness using the 6-Minute Walk Test (6MWT) assessed at the pre-surgery time point. The 6MWT is performed with participants walking up and down a 20 m course marked by cones for 6 min under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions is used as per the European Respiratory Society guidelines. The 6MWT is a validated assessment of cardiorespiratory function in clinical populations.
次要结局
- Change in Cognition- FACT-Cog(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Health Related Quality of Life (HrQoL)- FACT-G(2-6 weeks surgery, 6 weeks post surgery)
- Change in Cognitive Reserve-Cognitive Reserve Index (CR-IQ)(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Strength - The Stand to Sit Test(2-6 weeks pre-surgery, 6 weeks post-surgery)
- Change in Psychological Stress- Impact of Events Scale(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Health Related Quality of Life (HrQoL)-EQ-5D-5L (5L)(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Strength - The Handgrip Test(2-6 weeks pre-surgery, 6 weeks post-surgery)
- Change in Activity - 3-day ActivPAL3 triaxial accelerometer(2-6 weeks pre-surgery, 6 weeks post-surgery)
- Change in Psychological Stress(2-6 weeks pre-surgery, 6 weeks post-surgery)
- Change in Self-Efficacy(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Dietary Intake - Foodbook24(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Nutritional Status-The Malnutrition Screening Tool(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Nutritional Status- Glasgow Prognostic Score(2-6 weeks pre-surgery, 6 weeks post surgery)
- Change in Nutritional Status- Blood Screening(2-6 weeks pre-surgery, 6 weeks post surgery)
研究者
Aideen Scriney
Co-Investigator
Dublin City University