Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery
P2R-OncoVis
From Prehabilitation to Rehabilitation: A Feasibility Trial for Digitally Supported Prehabilitation in Major Visceral Oncologic Surgery
2 other identifiers
interventional
30
1 country
2
Brief Summary
Major visceral oncologic surgery is associated with high postoperative morbidity, prolonged hospitalization, delayed recovery, and reduced quality of life. Patients undergoing surgery of the pancreas, liver, bile ducts, stomach, or esophagus frequently present with reduced physical fitness, malnutrition, sarcopenia, and psychological distress, all of which may negatively affect surgical outcomes and rehabilitation. Although prehabilitation has shown potential to improve functional capacity before surgery, structured prehabilitation pathways are currently not routinely implemented in Austria, and the feasibility of digitally supported perioperative care pathways remains insufficiently evaluated. The aim of the Prehab2Rehab-OncoVis study is to evaluate the feasibility, acceptability, and safety of a multimodal, digitally supported prehabilitation intervention for patients undergoing major visceral oncologic surgery with curative intent. The study will additionally explore potential effects on clinical recovery, functional capacity, rehabilitation outcomes, and patient-reported outcomes across the perioperative pathway. Prehab2Rehab-OncoVis is designed as a prospective, single-arm feasibility cohort study conducted at the University Hospital Salzburg and the University Institute of Sports Medicine, Prevention and Rehabilitation, coordinated by the Paracelsus Medical University in cooperation with the Ludwig Boltzmann Institute for Rehabilitation Research and the Ludwig Boltzmann Institute for Digital Health and Prevention within the Prehab2Rehab consortium. Approximately 30 adult patients, with the possibility to include up to 50 participants if feasible, will be consecutively recruited. The intervention consists of a four-week multimodal prehabilitation program combining supervised exercise training, promotion of physical activity, nutritional counseling, psycho-oncological distress screening, and health literacy support. Digital tools will support the intervention throughout the perioperative pathway, including the HERO application (Das Herz Reha-Informationstool) for patient education and health literacy, aktivplan as a digital exercise planner and training diary, and the CAATS telecommunication platform for remote supervision and tele-prehabilitation sessions where appropriate. The exercise intervention includes supervised center-based sessions and, for participants with longer travel distances, a hybrid model combining center-based and tele-prehabilitation sessions. Nutritional counseling will follow current European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines and includes screening for malnutrition risk. Psycho-oncological distress screening will follow recommendations of the German Cancer Society and includes referral to supportive care when clinically indicated. Participants will be assessed throughout the perioperative pathway, including at the beginning and end of prehabilitation (Prehabilitation Assessment 1 \[PRE1\] and Prehabilitation Assessment 2 \[PRE2\]), during hospitalization and rehabilitation, and at a three-month follow-up after surgery. Primary outcomes focus on feasibility, including recruitment and retention rates, adherence, fidelity, safety, data management feasibility, and acceptability and usability of the digital technologies. Secondary outcomes include clinical recovery indicators, postoperative complications, length of hospital and intensive care stay, functional independence, psychological well-being, quality of life, body composition, cardiorespiratory fitness, functional exercise capacity, and muscle strength. To contextualize outcomes, two historical comparator cohorts will be used: a local hospital cohort of patients who previously underwent similar surgery without prehabilitation, and a national rehabilitation cohort derived from routine rehabilitation datasets matched for diagnosis, sex, and age. The study is intended to generate feasibility data and preliminary estimates that may support the development of future adequately powered randomized controlled trials evaluating digitally supported prehabilitation and rehabilitation pathways in visceral oncologic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 5, 2026
CompletedFirst Posted
Study publicly available on registry
June 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
June 18, 2026
May 1, 2026
1 year
June 5, 2026
June 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Recruitment Rate
The recruitment rate will be calculated as the percentage of eligible patients who consent to participate in the study. The reported value will be: (number of enrolled participants / number of eligible patients) × 100%.
Continuous throughout the recruitment period (12 months recruitment period)
Retention Rate
The retention rate will be calculated as the percentage of enrolled participants who complete the study according to the protocol. The reported value will be: (number of participants completing the study / number of enrolled participants) × 100%.
Continuous throughout the data collection period (12 months data collection period).
Communication with Participants
Communication with participants will be assessed by documenting the schedule and duration of communication between participants and study staff to address operational and intervention-related issues throughout the study.
Continuous throughout the study period (12 months study period).
Data collection and entry
Data collection and entry will be assessed by documenting the time required for data handling and the performance of the data collection and entry systems throughout the study.
Continuous throughout the data collection period (12 months data collection period).
Adherence to the Prehabilitation intervention
Adherence will be assessed as the average proportion of prescribed prehabilitation sessions attended by participants. The reported value will be: (number of completed sessions / number of prescribed sessions) × 100%.
Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days).
Fidelity to the Intervention
Fidelity will be assessed as the proportion of intervention components delivered according to the study protocol and planned intervention procedures. The reported value will be: (number of intervention components delivered as planned / number of planned intervention components) × 100%.
Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days).
Number of Intervention-Related Adverse Events (Safety)
Safety will be assessed based on the number and type of serious and non-serious adverse events considered related or possibly related to the intervention or study procedures. All adverse events will be documented throughout the study.
Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days).
Acceptability
Acceptability and user experience of the digital technologies will be assessed using the Mobile Application Rating Scale (MARS), a multidimensional questionnaire evaluating engagement, functionality, aesthetics, and information quality. Scores range from 1 to 5, with higher scores indicating better perceived quality and user experience.
Continuous throughout the study period (~12 months).
Secondary Outcomes (44)
Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2)
End of Rehabilitation (~ 17 weeks after Baseline).
mHealth App Usability Questionnaire (MAUQ)
End of Rehabilitation (~ 17 weeks after Baseline).
Perceived Hedonic and Pragmatic Quality Questionnaire (AttrakDiff)
End of Rehabilitation (~ 17 weeks after Baseline).
Affinity for Technology Interaction (ATI)
Baseline (Onset of Prehabilitation intervention).
Time to Functional Recovery (TtFR)
Hospital stays (10 to 21 days post-surgery).
- +39 more secondary outcomes
Study Arms (1)
Digitally Supported Multimodal Prehabilitation
EXPERIMENTALParticipants scheduled for major visceral oncologic surgery will undergo a four week multimodal digitally supported prehabilitation intervention before surgery. The intervention includes supervised exercise training, home based physical activity, nutritional counseling, psycho oncological distress screening, health literacy support, and perioperative optimization. Digital support will be provided through the HERO application, aktivplan, and CAATS to support education, communication, self management, and continuity of care across the perioperative pathway, including the transition from hospital discharge to inpatient rehabilitation.
Interventions
Multimodal digitally supported prehabilitation consisting of supervised exercise training, nutritional counseling, psycho-oncological distress screening, and health literacy support before major visceral oncologic surgery. The exercise intervention includes endurance, resistance, mobility, and breathing exercises delivered either as three supervised center-based sessions per week or as a hybrid model combining one center-based session with two tele-prehabilitation sessions weekly for patients with longer travel distances. Participants are additionally encouraged to maintain home-based physical activity. Digital support is provided through the HERO application for health literacy and patient education, aktivplan as a digital exercise planner and training diary, and the CAATS platform for tele-prehabilitation and remote consultations.
Eligibility Criteria
You may qualify if:
- Adults aged 18 years or older
- Clinical diagnosis requiring major surgery of the pancreas, liver, bile ducts, stomach, or esophagus with curative intent
- Confirmed indication for surgery by the multidisciplinary tumor board
- Medical stability and physician clearance to participate in a prehabilitation exercise program
- Willingness and ability to attend center-based prehabilitation exercise sessions three times per week, or once per week with additional tele-prehabilitation if travel time exceeds 40 minutes one way
- Willingness and ability to perform home-based physical activities
- Sufficient German language proficiency and digital literacy
- Access to a smartphone or tablet device with internet connection
- Provision of written informed consent
You may not qualify if:
- Age younger than 18 years
- Physical disability or mental impairment preventing safe participation in the study
- Health care medical power of attorney not permitting independent consent
- Non-elective, emergency, or revision surgery
- Acute medical condition contraindicating participation in a structured prehabilitation program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rehabilitationszentrum St. Veit im Pongau Betriebs-GmbH
Saint Veit Im Pongau, State of Salzburg, 5621, Austria
Department of General, Visceral and Thoracic Surgery, Paracelsus Medical University, Salzburger Landeskliniken, University Institute of Sports Medicine, Prevention and Rehabilitation
Salzburg, State of Salzburg, 5020, Austria
Related Publications (4)
Faqar-Uz-Zaman SF, Sliwinski S, Detemble C, Filmann N, Zmuc D, Mohr L, Dreilich J, Bechstein WO, Fleckenstein J, Schnitzbauer AA. Study protocol for a pilot trial analysing the usability, validity and safety of an interventional health app programme for the structured prehabilitation of patients before major surgical interventions: the PROTEGO MAXIMA trial. BMJ Open. 2023 Apr 5;13(4):e069394. doi: 10.1136/bmjopen-2022-069394.
PMID: 37019492BACKGROUNDBarberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PMID: 28489682BACKGROUNDMinnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
PMID: 30193337BACKGROUNDMolenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
PMID: 35588252BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Löb, Priv.-Doz. Dr. med.
Department of General, Visceral and Thoracic Surgery, Paracelsus Medical University, Salzburger Landeskliniken
- STUDY DIRECTOR
Daniela Wurhofer, Dr.
Ludwig Boltzmann Institute for Digital Health and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2026
First Posted
June 18, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
June 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared in order to protect participant confidentiality and in accordance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Only aggregated and fully anonymized data will be reported in scientific publications and presentations. No individual-level data will be made publicly available. Access to underlying data may be considered upon reasonable request and subject to institutional, ethical, and legal approval.