Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLudwig Boltzmann Institute for Digital Health and Prevention

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Digitally Supported Multimodal Prehabilitation

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Digitally Supported Multimodal PrehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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%.

Time frame
Continuous throughout the recruitment period (12 months recruitment period)
2

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%.

Time frame
Continuous throughout the data collection period (12 months data collection period).
3

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.

Time frame
Continuous throughout the study period (12 months study period).
4

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.

Time frame
Continuous throughout the data collection period (12 months data collection period).

Secondary outcomes

1

Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2)

Technology acceptance will be assessed using the Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2) questionnaire. Higher scores indicate greater acceptance and intention to use the digital support technologies.

Time frame
End of Rehabilitation (~ 17 weeks after Baseline).
2

mHealth App Usability Questionnaire (MAUQ)

Usability of the digital support technologies will be assessed using the mHealth App Usability Questionnaire (MAUQ). Higher scores indicate greater perceived usability and user satisfaction.

Time frame
End of Rehabilitation (~ 17 weeks after Baseline).
3

Perceived Hedonic and Pragmatic Quality Questionnaire (AttrakDiff)

User experience of the digital support technologies will be assessed using the Perceived Hedonic and Pragmatic Quality Questionnaire (AttrakDiff). Higher scores indicate a more positive perceived user experience.

Time frame
End of Rehabilitation (~ 17 weeks after Baseline).
4

Affinity for Technology Interaction (ATI)

Affinity for Technology Interaction (ATI) will be used to assess the individual's tendency to actively engage with and use technology in daily life. Higher scores indicate greater affinity for technology interaction.

Time frame
Baseline (Onset of Prehabilitation intervention).

Other outcomes

Sponsors and contacts

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Ludwig Boltzmann Institute for Digital Health and Prevention

Lead sponsor

Salzburger Landeskliniken

Collaborator

Paracelsus Medical University

Collaborator

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