Wearable-Supported Prehabilitation and Rehabilitation for Patients Undergoing Surgery for Pancreatic Cancer

NCT07772258 | Not Yet Recruiting

• 2 other identifiers: B02760ERP-2025-14388
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Cancer; Pancreatic Neoplasms; Periampullary Carcinoma; Pancreatic Surgery; Perioperative Care

Keywords

Pancreatic Cancer; Pancreatic Surgery; Perioperative Care; Rehabilitation; Prehabilitation; Exercise; Nutrition; Wearables; Remote Monitoring; Digital Health; Mobile Health; Recovery of Function; Patient Monitoring; Telemedicine; Surgical Oncology; PROMS; Electronic Devices

Outcome Measures

Primary Outcomes (1)

• Post-operative complications

  Occurrence of post-operative complications following pancreatic surgery.

  30 and 90 days post-surgery

Secondary Outcomes (6)

• 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.

Study Arms (2)

Wearable-Enabled Prehabilitation and Rehabilitation

EXPERIMENTAL

Participants undergoing pancreatic surgery will receive the Greater Manchester Prehab4Cancer programme supported by wearable monitoring, home physiological monitoring, and remote follow-up throughout the perioperative pathway. Outcomes will be compared with a propensity-score-matched historical cohort identified from routine electronic health records.

Device: Corsano CardioWatch; Behavioral: Prehab4Cancer Programme

Matched Historical Standard Care Cohort

NO INTERVENTION

Historical patients who underwent pancreatic surgery and received standard perioperative care without wearable monitoring. Participants will be identified retrospectively from electronic health records and matched to intervention participants using propensity score methods based on demographic and clinical characteristics. No study intervention will be delivered.

Interventions

Corsano CardioWatch DEVICE

A wearable monitoring device used throughout the perioperative pathway to collect continuous physiological and activity data, including measures such as physical activity, heart rate, respiratory rate, oxygen saturation, skin temperature, and sleep-related metrics.

Wearable-Enabled Prehabilitation and Rehabilitation

Prehab4Cancer Programme BEHAVIORAL

A personalised prehabilitation and rehabilitation programme comprising exercise, nutritional support, and wellbeing support delivered before and after pancreatic surgery.

Wearable-Enabled Prehabilitation and Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic: collaborator
• Manchester University NHS Foundation Trust: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Lukas Hughes-Noehrer, PhD

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynne Webster

CONTACT

00441612764125; lynne.webster@mft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 19, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) will become available following publication of the primary study results and completion of the final study report. Data are expected to be available beginning approximately 6 to 12 months after publication of the primary study findings. Anonymised participant-level datasets and supporting documentation may remain available for up to 10 years following study completion, in accordance with the study protocol and Manchester University NHS Foundation Trust data retention policies. Data sharing will be subject to appropriate governance approvals, data-sharing agreements, and applicable legal and regulatory requirements. Supporting materials, including the study protocol, data dictionary, and statistical analysis methods, may also be made available during this period.
• Access Criteria: Anonymised individual participant data (IPD) and supporting documentation may be made available to researchers following publication of the primary study results. Data that may be shared include demographic variables, clinical outcomes, patient-reported outcome measures, and wearable-derived physiological and activity data relevant to the published analyses. Access requests must be methodologically sound and for scientifically valid research purposes. Requests will be reviewed by the Chief Investigator and Manchester University NHS Foundation Trust in accordance with participant consent, applicable ethics approvals, data protection legislation, and data-sharing agreements. Data will only be released in a fully anonymised form and through secure data-sharing mechanisms. Supporting documents, including the study protocol, data dictionary, and statistical analysis methods, may also be made available where appropriate.