ClinicalTrials.gg
Not yet recruitingNCT07772258POWR-PaCUpdated Aug 19, 2026

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

An interventional study of Corsano CardioWatch and Prehab4Cancer Programme in Pancreatic Cancer, Pancreatic Neoplasms and Periampullary Carcinoma, sponsored by Manchester University NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Manchester University NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

The primary clinical evaluation will focus on post-operative morbidity within 30 and 90 days of surgery. Secondary analyses will assess measures including mortality, hospital utilisation, days alive and out of hospital, functional recovery, quality of life, and engagement with prehabilitation and rehabilitation services. Exploratory analyses will investigate whether longitudinal wearable data can provide early indicators of recovery status, post-operative complications, or treatment response.

The study also incorporates a mixed-methods evaluation of implementation. Participants, healthcare professionals, and exercise specialists may be invited to take part in qualitative focus groups to explore experiences of wearable-supported care, barriers and facilitators to adoption, usability of the technology, and opportunities for future pathway optimisation. Qualitative findings will be used to inform the future design, implementation, and scale-up of digitally enabled perioperative pathways within NHS surgical services.

The findings from POWR-PaC will provide evidence regarding the feasibility, acceptability, and potential clinical value of integrating wearable technologies into perioperative cancer care and will inform the development of larger effectiveness studies and future digitally enabled surgical pathways.

02

Conditions studied

  • 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
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 120 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged 18 years or older.
  • Able to provide .
  • 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

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to provide .
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Wearable-Enabled Prehabilitation and Rehabilitation

    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

  • No intervention
    Matched Historical Standard Care Cohort

    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

  • DeviceCorsano CardioWatch

    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.

  • BehavioralPrehab4Cancer Programme

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

06

What researchers measure

Primary outcomes

  1. Post-operative complications

    Occurrence of post-operative complications following pancreatic surgery.

    Time frame: 30 and 90 days post-surgery

Secondary outcomes

  1. All-cause mortality

    All-cause mortality post-surgery

    Time frame: 30, 90, 365 days post-surgery.

  2. Days Alive and Out of Hospital (DAOH)

    Number of days participants are alive and not admitted to hospital during the preoperative period (from enrolment to surgery) and during the postoperative recovery period. DAOH incorporates mortality, length of stay, and hospital readmissions into a single patient-centred outcome measure.

    Time frame: From enrolment to date of surgery (preoperative period); and from date of surgery to 30, 90, and 365 days post-operatively (postoperative period).

  3. Length of Stay

    Number of days spent in hospital during the index surgical admission following pancreatic resection.

    Time frame: From date of surgical resection to date of discharge from the index hospital admission, assessed up to 90 days post-surgery.

  4. Completeness of Wearable Data Collected via Corsano CardioWatch

    Percentage of expected physiological and activity data points (heart rate, SpO2, activity, sleep) successfully captured and transmitted, relative to the total expected monitoring period. Unit: percentage

    Time frame: From enrolment until completion of the rehabilitation programme, up to 12 months post-surgery.

  5. Participant Adherence to Wearable Device Wear Time

    Percentage of prescribed daily wear/use time achieved by participants. Unit: percentage

    Time frame: From enrolment until completion of the rehabilitation programme, up to 12 months post-surgery.

  6. Technical Feasibility of Wearable Device Data Collection

    Number of technical issues (device malfunction, connectivity failure, data transmission gaps) encountered with the Corsano CardioWatch. Unit: count

    Time frame: From enrolment until completion of the rehabilitation programme, up to 12 months post-surgery.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data underlying the results reported in publications arising from this study may be shared in an anonymised form following completion of the study and publication of the primary results. Shared datasets may include demographic data, clinical characteristics, patient-reported outcome measures, wearable-derived physiological and activity data, and key outcome variables relevant to the published analyses. Data will be fully anonymised prior to sharing and no directly identifiable information will be released. Access will be subject to approval by Manchester University NHS Foundation Trust, compliance with applicable data sharing agreements, participant consent, UK GDPR, research governance requirements, and any relevant ethical approvals. Supporting documentation, including the study protocol, statistical analysis methods, and data dictionary, may also be made available where appropriate.

Supporting information: Study protocol, Statistical analysis plan, 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Mar 2028, 17 months later.

Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 17 months is below that.

Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2026
First posted
Aug 19, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Mar 31, 2028
CompletionEst.
Sep 30, 2028
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07772258
Collaborators
Medtronic
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Mar 31, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Aug 19, 2026

Study contacts

Lynne Webster
Contact
lynne.webster@mft.nhs.uk
00441612764125
Lukas Hughes-Noehrer, PhD
principal investigator · Manchester University NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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