Perioperative Optimisation and Wearable Remote Monitoring of Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Post-operative complications
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a wearable-enabled prehabilitation and rehabilitation pathway can improve recovery and post-operative outcomes in adults undergoing surgery for pancreatic cancer or related pancreatic/periampullary conditions.
The main questions it aims to answer are:
Does a wearable-enabled prehabilitation and rehabilitation programme reduce post-operative complications within 30 and 90 days after surgery? Is the use of wearable devices and remote monitoring feasible, acceptable, and useful for patients and healthcare professionals during the perioperative pathway?
Researchers will compare patients receiving the wearable-enabled pathway with a matched historical control group who received standard care to determine whether the intervention is associated with improved surgical and recovery outcomes.
Participants will:
Provide informed consent and complete baseline assessments and questionnaires. Take part in the Greater Manchester Prehab4Cancer programme before surgery, including personalised exercise, nutritional support, and wellbeing support.
Wear a Corsano CardioWatch device to continuously monitor physiological and activity data.
Use home monitoring equipment, including weight scales and blood pressure monitoring devices.
Complete questionnaires and participant logs during prehabilitation and recovery.
Receive regular support from the research team during participation. Undergo pancreatic surgery and receive standard NHS perioperative care. Continue wearable monitoring and rehabilitation after hospital discharge. Be followed for up to 12 months after surgery using routine clinical data to assess recovery, complications, hospital utilisation, and survival.
Optionally participate in a focus group to discuss their experiences of wearable-enabled care.
详细描述
POWR-PaC (Perioperative Optimisation and Wearable Remote monitoring of Pancreatic Cancer) is a prospective, single-centre study evaluating the integration of wearable technologies into an established perioperative prehabilitation and rehabilitation pathway for patients undergoing pancreatic surgery. The study is being conducted at Manchester University NHS Foundation Trust in partnership with the Greater Manchester Prehab4Cancer programme.
Major pancreatic surgery is associated with substantial morbidity, prolonged recovery, and significant variation in patient outcomes. Although prehabilitation programmes have demonstrated benefits for physical fitness and surgical preparedness, there is limited evidence regarding the role of continuous physiological monitoring and remote assessment throughout the perioperative pathway. Wearable technologies may provide objective, longitudinal measures of activity, sleep, cardiovascular function, recovery trajectories, and treatment tolerance that are not routinely captured during standard care.
Participants enrolled in the intervention arm will be prescribed the targeted Greater Manchester Prehab4Cancer pathway and will additionally receive a wearable monitoring package consisting of a Corsano CardioWatch device and supporting home monitoring equipment. Physiological and behavioural measures collected by the wearable system may include physical activity, heart rate, respiratory rate, oxygen saturation, skin temperature, sleep-related metrics, and other device-derived indicators. Weight and blood pressure measurements will also be collected using home monitoring equipment where applicable.
Data collection will occur across the perioperative pathway, including the pre-operative prehabilitation period, inpatient surgical admission, and post-operative rehabilitation phase. Clinical, functional, physiological, and patient-reported outcome measures will be collected alongside routinely recorded healthcare data. The study will evaluate data completeness, participant adherence, acceptability of remote monitoring, and the potential relationship between wearable-derived metrics and clinical outcomes.
A matched historical control cohort will be identified from electronic health records at Manchester University NHS Foundation Trust. Control participants will have undergone pancreatic surgery and standard perioperative care without participation in the wearable-enabled pathway. Matching methods will be used to minimise baseline differences between groups and support comparative analyses of clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients aged 18 years or older.
- •Able to provide informed consent.
- •Able to use the study devices independently or with support from a carer.
- •Approved for pancreatic cancer surgery, including patients undergoing surgery for:
- •Pancreatic cancer Distal cholangiocarcinoma Ampullary carcinoma Duodenal carcinoma Premalignant pancreatic lesions, including Intraductal Papillary Mucinous Neoplasms (IPMNs).
- •Clinically stable and considered suitable to participate in the prehabilitation and rehabilitation programme.
- •Owns a smartphone or tablet device
排除标准
- •Unable or unwilling to provide informed consent.
- •Lacks capacity to provide informed consent.
- •Unstable angina pectoris.
- •Recent myocardial infarction.
- •Recent cerebrovascular accident (stroke).
- •New cardiac arrhythmia.
- •Social, physical, mental health, or substance misuse issues that, in the opinion of the investigator, would jeopardise adherence to study procedures or study contact.
- •No infrastructure for remote monitoring (no access to either mobile signal or Wi-Fi).
- •Clinically unstable or likely to require hospital admission within the next 72 hours.
- •Unable to use the study devices and no carer or support person is available to assist.
结局指标
主要结局
Post-operative complications
时间窗: 30 and 90 days post-surgery
Occurrence of post-operative complications following pancreatic surgery.
次要结局
- All-cause mortality(30, 90, 365 days post-surgery.)
- Days Alive and Out of Hospital (DAOH)(From enrolment to date of surgery (preoperative period); and from date of surgery to 30, 90, and 365 days post-operatively (postoperative period).)
- Length of Stay(From date of surgical resection to date of discharge from the index hospital admission, assessed up to 90 days post-surgery.)
- Completeness of Wearable Data Collected via Corsano CardioWatch(From enrolment until completion of the rehabilitation programme, up to 12 months post-surgery.)
- Participant Adherence to Wearable Device Wear Time(From enrolment until completion of the rehabilitation programme, up to 12 months post-surgery.)
- Technical Feasibility of Wearable Device Data Collection(From enrolment until completion of the rehabilitation programme, up to 12 months post-surgery.)