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Not yet recruiting NCT07658313

Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery

No phase Interventional Gastrointestinal Neoplasms Pancreatic Neoplasms Liver Neoplasm Oesophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digitally Supported Multimodal Prehabilitation.
Who it may be relevant to
Registry conditions: Gastrointestinal Neoplasms, Pancreatic Neoplasms, Liver Neoplasm, Oesophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

From Prehabilitation to Rehabilitation: A Feasibility Trial for Digitally Supported Prehabilitation in Major Visceral Oncologic Surgery

Overview

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.

Detailed description

Major visceral oncologic surgery remains one of the most physiologically demanding therapeutic interventions in modern cancer care. Patients undergoing surgery of the pancreas, liver, bile ducts, stomach, or esophagus frequently present with reduced physical reserve, impaired nutritional status, sarcopenia, cancer-related fatigue, reduced exercise tolerance, psychological distress, and multiple comorbidities. These factors contribute substantially to postoperative morbidity, prolonged recovery, delayed rehabilitation, reduced quality of life, and increased health care utilization.

Despite advances in surgical and perioperative care, postoperative complications remain common after major visceral oncologic surgery. Functional decline following surgery may additionally impair the initiation or completion of adjuvant oncologic therapies, potentially affecting long-term prognosis. Therefore, strategies that optimize patients before surgery and support continuity of recovery throughout the perioperative pathway are increasingly recognized as clinically relevant.

Prehabilitation aims to improve the physiological and psychological readiness of patients before surgery through targeted interventions, commonly including exercise training, nutritional optimisation, psychological support, and health education. Previous studies have shown that prehabilitation may improve functional capacity and may contribute to improved postoperative recovery. However, important gaps remain regarding implementation feasibility, integration into routine clinical care, long-term continuity between prehabilitation and rehabilitation, and the role of digital technologies in supporting patient engagement and adherence.

In Austria, structured prehabilitation pathways are currently not routinely implemented for patients undergoing major visceral oncologic surgery. Furthermore, perioperative care pathways often remain fragmented, particularly during the transition from surgical hospitalization to rehabilitation. Digital technologies have the potential to improve continuity of care, facilitate communication, support self-management, and improve adherence to exercise and rehabilitation programs. Nevertheless, the feasibility and acceptance of digitally supported perioperative pathways in this patient population remain insufficiently investigated.

The Prehab2Rehab-OncoVis study was therefore developed to evaluate the feasibility, safety, acceptability, and implementation characteristics of a multimodal digitally supported prehabilitation pathway extending from preoperative preparation through rehabilitation and follow-up. The study additionally aims to generate preliminary clinical and functional outcome data that may support the planning of future randomized controlled trials.

The study is conducted at the University Hospital Salzburg and the University Institute of Sports Medicine, Prevention and Rehabilitation in cooperation with the Ludwig Boltzmann Institute for Rehabilitation Research and the Ludwig Boltzmann Institute for Digital Health and Prevention within the framework of the Prehab2Rehab consortium.

The study is designed as a prospective single-arm feasibility cohort study. Approximately 30 adult patients scheduled for major visceral oncologic surgery with curative intent will be consecutively recruited, with the possibility of including up to 50 participants if feasible within the recruitment period. Historical comparison cohorts will additionally be used to contextualize observed outcomes. These include 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 primary objective of the study is to evaluate feasibility outcomes associated with the implementation of the digitally supported multimodal prehabilitation intervention. Feasibility outcomes include recruitment rate, retention rate, communication with participants, data collection and data management performance, adherence to the intervention, intervention fidelity, safety, and acceptability of the digital technologies.

Recruitment feasibility will be evaluated by documenting the proportion of eligible patients who provide written informed consent for study participation. Retention feasibility will be assessed by determining the proportion of enrolled participants who complete the intervention and study assessments. Intervention adherence will be assessed through attendance at supervised sessions, completion of prescribed activities, and use of the digital tools. Fidelity will evaluate the degree to which the intervention is implemented according to the planned protocol and standardized procedures.

Acceptability and usability of the digital tools will be evaluated using validated questionnaires, including the Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2), the mHealth App Usability Questionnaire (MAUQ), the Mobile Application Rating Scale (MARS), AttrakDiff, and the Affinity for Technology Interaction (ATI) questionnaire. In addition, qualitative participant experiences will be explored through semi-structured interviews performed after completion of the intervention pathway.

The intervention consists of a multimodal prehabilitation program combining supervised exercise training, nutritional counseling, psycho-oncological distress screening, promotion of health literacy, and digitally supported patient engagement. The exercise intervention follows a structured multimodal approach and is individualized according to medical evaluation, baseline functional capacity, and therapist judgment. The intervention is delivered in two formats depending on travel distance and feasibility.

Participants living within practical traveling distance of the training center participate in a standard center-based exercise program consisting of three supervised exercise sessions per week at the University Institute of Sports Medicine, Prevention and Rehabilitation. Participants with travel times exceeding approximately 40 minutes one way may participate in a hybrid model consisting of one supervised center-based session and two remotely supervised tele-prehabilitation sessions per week.

Exercise sessions are structured according to the Frequency, Intensity, Time, and Type (FITT) principles and include warm-up, endurance training, resistance training, and cool-down phases. Endurance exercise is primarily performed on stationary cycle ergometers at moderate intensity. Resistance exercise includes machine-based or elastic-band-based exercises targeting major muscle groups. Exercise intensity and progression are adapted individually according to baseline assessment, perceived exertion, and clinical status. During supervised endurance exercise sessions, patient safety is ensured through clinical supervision by exercise therapists and physicians. Electrocardiographic monitoring may be used when clinically indicated. Emergency procedures and emergency equipment are available during all center-based sessions.

The hybrid tele-prehabilitation sessions are conducted using the CAATS telecommunication platform. During remote sessions, participants receive live visual supervision from the therapist. If adequate visual supervision cannot be established, the tele-prehabilitation session is not conducted. The tele-prehabilitation format was developed to improve feasibility and accessibility for participants living farther away from the training center while maintaining structured supervision and continuity.

Participants are additionally encouraged to maintain an active lifestyle outside supervised sessions. Home-based physical activity recommendations include regular walking and low-to-moderate intensity activities integrated into daily life. Physical activity guidance is progressively adapted across the intervention period.

Nutritional counseling is performed in parallel with the exercise intervention and follows current European Society for Clinical Nutrition and Metabolism (ESPEN) recommendations for clinical nutrition in surgery. Nutritional screening includes assessment using the Nutritional Risk Screening 2002 score (NRS-2002). Individualized counseling aims to optimize preoperative nutritional status and ensure adequate caloric and protein intake. When clinically indicated, oral nutritional supplementation may be recommended. Nutritional counseling is primarily delivered through face-to-face consultations but may additionally be supported through teleconsultation using the CAATS platform.

Psycho-oncological distress screening is integrated into the intervention pathway in accordance with recommendations of the German Cancer Society and psycho-oncological guidelines. Screening includes use of the National Comprehensive Cancer Network (NCCN) Distress Thermometer and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants exceeding predefined thresholds or requesting support may be referred for psycho-oncological counseling and supportive care according to standard clinical pathways.

Health literacy promotion represents an additional core component of the intervention. Health literacy is evaluated using the European Health Literacy Questionnaire (HLS-EU-Q) and the Brief Health Literacy Screening Tool (BRIEF). Educational support is provided using the HERO application. The HERO application was developed to provide structured evidence-based information throughout the perioperative pathway. The application includes educational material regarding disease-related information, surgery, rehabilitation, physical activity, recovery processes, and patient orientation. The HERO application serves exclusively as an educational and motivational support tool and is not intended as a diagnostic or therapeutic medical device.

The aktivplan application is used as a digital exercise planner and training diary. It allows participants to access prescribed exercise sessions, document completed activities, receive reminders, and maintain an overview of their training schedule. The application additionally supports adherence monitoring and allows the study team to evaluate engagement and implementation fidelity. Together, HERO, aktivplan, and CAATS form an integrated digital support environment intended to facilitate continuity between prehabilitation, surgery, transition, rehabilitation, and recovery.

The perioperative pathway assessed within the study includes multiple predefined phases and assessment time points. Baseline assessments are performed at the start of prehabilitation (Prehabilitation Assessment 1 \[PRE1\]). Repeat assessments are conducted after completion of the prehabilitation intervention but before surgery (Prehabilitation Assessment 2 \[PRE2\]). Surgical hospitalization and postoperative recovery are subsequently documented. Rehabilitation-related assessments are performed at admission to rehabilitation (Rehabilitation Assessment 1 \[REH1\]) and at discharge from rehabilitation (Rehabilitation Assessment 2 \[REH2\]). A final follow-up assessment is conducted approximately three months after surgery.

The rehabilitation phase itself is conducted as usual care without modification of standard rehabilitation procedures. However, participants who undergo rehabilitation at the affiliated rehabilitation center are systematically followed to evaluate rehabilitation outcomes and user experiences across the complete treatment pathway.

Secondary outcomes are exploratory and intended to provide preliminary information regarding potential effects of the intervention on clinical, functional, physiological, and patient-reported outcomes. Clinical recovery indicators include time to functional recovery, postoperative complications, Comprehensive Complication Index, length of intensive care unit stay, length of hospital sta

Interventions

  • Behavioral Digitally Supported Multimodal Prehabilitation
    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 wi

Primary outcome measures

  • Recruitment Rate [Time frame: Continuous throughout the recruitment period (12 months recruitment period)]
  • Retention Rate [Time frame: Continuous throughout the data collection period (12 months data collection period).]
  • Communication with Participants [Time frame: Continuous throughout the study period (12 months study period).]
  • Data collection and entry [Time frame: Continuous throughout the data collection period (12 months data collection period).]
  • Adherence to the Prehabilitation intervention [Time frame: Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days).]
  • Fidelity to the Intervention [Time frame: Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days).]
  • Number of Intervention-Related Adverse Events (Safety) [Time frame: Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days).]
  • Acceptability [Time frame: Continuous throughout the study period (~12 months).]
Secondary outcome measures (12)
  • Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2) [Time frame: End of Rehabilitation (~ 17 weeks after Baseline).]
  • mHealth App Usability Questionnaire (MAUQ) [Time frame: End of Rehabilitation (~ 17 weeks after Baseline).]
  • Perceived Hedonic and Pragmatic Quality Questionnaire (AttrakDiff) [Time frame: End of Rehabilitation (~ 17 weeks after Baseline).]
  • Affinity for Technology Interaction (ATI) [Time frame: Baseline (Onset of Prehabilitation intervention).]
  • Time to Functional Recovery (TtFR) [Time frame: Hospital stays (10 to 21 days post-surgery).]
  • Length of Hospital Stay (LOHS) [Time frame: Hospital stays (10 to 21 days post-surgery).]
  • Comprehensive Complication Index (CCI) [Time frame: Hospital stays (10 to 21 days post-surgery).]
  • Length of Intensive Care Unit Stay (LoICU) [Time frame: Hospital stays (10 to 21 days post-surgery).]
  • 30-day Re-admission Rate (30dRR) [Time frame: Transition (~42 days post-surgery), and onset of Rehabilitation (~63 days post-surgery).]
  • 30-day Mortality Rate (30dMR) [Time frame: After surgery (~21 days), transition (~35 days), onset rehabilitation (~63 days post-surgery).]
  • 90-day Mortality Rate (90dMR) [Time frame: After surgery (~21 days), transition (~35 days), after rehabilitation (28 days), follow-up (~7 days after Rehabilitation)]
  • Barthel Index (BI) [Time frame: Baseline (Prehabilitation onset), onset Rehabilitation (~63 days post-surgery), and after Rehabilitation (~28 days).]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Austria · 2 centers
  • Rehabilitationszentrum St. Veit im Pongau Betriebs-GmbH — Saint Veit Im Pongau
  • Department of General, Visceral and Thoracic Surgery, Paracelsus Medical University, Salzb — Salzburg

Publications

  • 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: PMID 37019492
  • Barberan-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 28489682
  • Minnella 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 30193337
  • Molenaar 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 35588252

Identifiers

NCT: NCT07658313 · Prehab2Rehab-OncoVis · EK 1182/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗