Evidence map›Paper›PMID 41109944›Full record

ArticleBMC cancer2025

Digital and AI-assisted multimodal supportive care, combining physical activity, nutrition, and pain management during chemotherapy for advanced pancreatic cancer patients: study protocol of the European multicenter randomized controlled trial of the RELEVIUM project.

Barlo Hillen, Gabrielle Oestreicher, Lisa Schwab, Kira Enders, Perikles Simon, Anneli Elme, Irit Ben-Aharon, Tal Goshenlago, Cindy Neuzillet, Francesco Sclafani and 26 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors.

Barlo HillenInstitute of Sport Science, Dpt. Sports Medicine, Disease Prevention & Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany. b.hillen@uni-mainz.de.
Gabrielle OestreicherDepartment of Medicine 1, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. Gabrielle.Oestreicher@unimedizin-mainz.de.
Lisa SchwabInstitute of Sport Science, Dpt. Sports Medicine, Disease Prevention & Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.
Kira EndersInstitute of Sport Science, Dpt. Sports Medicine, Disease Prevention & Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.
Perikles SimonInstitute of Sport Science, Dpt. Sports Medicine, Disease Prevention & Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.
Anneli ElmePõhja-Eesti Regionaalhaigla, North Estonia Medical Centre, Tallinn, Estonia.
Irit Ben-AharonFishman Oncology Center, Rappaport Faculty of Medicine, Rambam Health Care Campus, Haifa, Israel.
Tal GoshenlagoFishman Oncology Center, Rappaport Faculty of Medicine, Rambam Health Care Campus, Haifa, Israel.
Cindy NeuzilletSaint-Cloud, University Versailles Saint-Quentin, France and Ambroise Paré University Hospital, Institute Curie, Boulogne-Billancourt, France.
Francesco SclafaniHôpital Universitaire de Bruxelles, Institut Jules Bordet - Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
Eva Ester Molina BeltranSaint-Cloud, University Versailles Saint-Quentin, France and Ambroise Paré University Hospital, Institute Curie, Boulogne-Billancourt, France.
Michael SchusterDepartment of Medicine 1, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
Hristina DonchevaROSENBAUM CONSULTING Ltd, Sofia, Bulgaria.
Christian RuckesInternational Center for Clinical Studies, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
Michael KarlecikROSENBAUM CONSULTING Ltd, Sofia, Bulgaria.
Katja PetrowskiDepartment of Medicine 1, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
David RosenbaumROSENBAUM CONSULTING Ltd, Sofia, Bulgaria.
Christos DiouHarokopio University of Athens, Athens, Greece.
Aristotelis BallasHarokopio University of Athens, Athens, Greece.
Aggeliki VlachostergiouEXUS AI Labs, Athens, Greece.
Davide MastricciEXUS AI Labs, Athens, Greece.
Alexander ScherrerFraunhofer Institute for Industrial Mathematics, Kaiserslautern, Germany.
Maximilian PilzFraunhofer Institute for Industrial Mathematics, Kaiserslautern, Germany.
Jonas FlechsigFraunhofer Institute for Industrial Mathematics, Kaiserslautern, Germany.
Lazaros ApostolidisCentre for Research & Technology Hellas, Thessaloniki, Greece.
Anna-Maria KrooupaCentre for Research & Technology Hellas, Thessaloniki, Greece.
Sai ChinthaMCS Datalabs, Berlin, Germany.
Isa Wasswa MusisiMCS Datalabs, Berlin, Germany.
Nefeli Panagiota TzavaraAINIGMA Technologies, Louvain, Germany.
Athanasios KakasisAINIGMA Technologies, Louvain, Germany.
Xenia HadjikypriCenter for Social Innovation LTD, Nicosia, Cyprus.
Styliani KarraCenter for Social Innovation LTD, Nicosia, Cyprus.
Kyriaki ChatzipanagiotouCenter for Social Innovation LTD, Nicosia, Cyprus.
Ioannis DrivasDiadikasia Business Consulting, Athens, Greece.
Hugo DacasaFuturo Perfecto Innovacion SL, Madrid, Spain.
Markus MoehlerDepartment of Medicine 1, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. Markus.Moehler@unimedizin-mainz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultimodal care, including nutritional support, physical exercise, and pain management, is essential to address complex therapeutic challenges in advanced pancreatic cancer. There is an increasing prevalence worldwide in pancreatic cancer and the disease is often diagnosed late leading to limited treatment options and poor prognosis. Advanced pancreatic cancer patients experience a wide range of adverse symptoms that affect their quality of life and require comprehensive and interdisciplinary patient care early in treatment. Integrating digital health, particularly through remote monitoring, plays a vital role in addressing the therapeutic challenges and improving data-driven clinical decision-making. Therefore, the European project RELEVIUM examines the effect of a personalized, digitally assisted multimodal supportive care intervention on health-related quality of life in patients with pancreatic cancer aiming to improve early access to multidisciplinary, cost-effective palliative care.

methodsIn cancer centers in Estonia, Israel, and Germany, 132 patients will be randomly assigned in the prospective randomized controlled trial RELEVIUM-RCT into two groups. Both groups receive standard chemotherapy. The control group follows usual care, while the intervention group receives personalized, digitally assisted multimodal support integrated into usual care. The intervention includes guidance and monitoring on pain, nutrition, fatigue, sarcopenia, and physical activity. Patients track their physical activities, nutritional behavior and rate pain and fatigue daily via a smartwatch and mobile app. The physician analyses these longitudinal data on a dashboard and counsels the patients every two weeks during clinical visits, assisted by an interdisciplinary team and digital support system. The primary endpoint of the study is health-related quality of life including factors such as time until a definitive deterioration in selected dimensions (physical functioning and/or appetite loss) assessed at 8 weeks. Secondary endpoints include longitudinal analyses of efficacy related to pain, physical function, nutrition, sarcopenia, and socioeconomic factors. DISCUSSION: The RELEVIUM-RCT investigates the efficacy of digital health support for individuals with advanced pancreatic cancer in conjunction with conventional treatments in three European countries. Longitudinal data on the interplay of chemotherapy toxicity, fatigue, pain, physical activity, and nutrition will provide valuable extended insights on multimodal pancreatic cancer care. Moreover, this data can help demonstrate the benefits of digital health in clinical decision-making, ultimately contributing to improved quality of care in Europe.

trial registrationRegistry: German Clinical Trials Register; Registration number: DRKS00037143; Date of registration: 5th of June 2025.

Indexed as

ExercisePain ManagementPalliative CarePancreatic NeoplasmsCombined Modality TherapyEuropeHumansMulticenter Studies as TopicNutritional SupportProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTelemedicineCachexiaChemotherapyDigital HealthNutritionPancreatic CancerPersonalized MedicinePhysical ActivitySarcopeniaSupportive CareTelemedicine

Identifiers

PMID41109944
PMCPMC12535004

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.