Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery

Sponsor
Ludwig Boltzmann Institute for Digital Health and Prevention
Study ID
NCT07658313
Status
Not Yet Recruiting

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Conditions

  • Cancer Rehabilitation
  • Gastrointestinal Cancer
  • Gastrointestinal Neoplasms
  • Liver Cancer
  • Liver Neoplasm
  • Oesophageal Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Prehabilitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Digitally Supported Multimodal Prehabilitation
    Participants 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.

Primary Outcome Measure

Recruitment Rate [ Time Frame: Continuous throughout the recruitment period (12 months recruitment period) ]

Central Contacts

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