AUTHOR=Kleve Guro , Santa Chiara Dalla , Kristiansen Felicia , Tegnander Marita , Buch Victoria , Hagemann Cecilie Steen , Helgheim Marianne , Engene Parasto , Pesonen Henri , Kleveland Maiken Kojen , Hverven Greta Lyster , Nilsen Tormod Skogstad , Vervaart Mathyn Adrianus Marinus , Aanesen Helle , Uglane Kari Thune , Bjelland Mona , Zory Raphaël , Chorin Frédéric , Cardot-Ruffino Victoire , Beltran Eva Ester Molina , Neuzillet Cindy , Soerensen Mette , Jylhävä Juulia , Anzar Irantzu , Normand Valentin André , Myrstad Marius , Klungland Arne , Nilsen Hilde Loge , Ougland Rune 

TITLE=Digital home-based multimodal prehabilitation of colorectal cancer patients prior to surgery (the dHOPE study): a non-inferiority clinical trial protocol

JOURNAL=Frontiers in Digital Health

VOLUME=Volume 7 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1609678

DOI=10.3389/fdgth.2025.1609678

ISSN=2673-253X

ABSTRACT=BackgroundCancer surgery is associated with risk of complications and loss of function. Vulnerability factors, such as advanced age, malnutrition, smoking, comorbidity, frailty, and low socioeconomic status increase the risk. Lifestyle intervention prior to surgery, known as prehabilitation, often include physical activity, nutritional support, psychological coaching, and smoking cessation, increase functional reserves and reduce postoperative complications. Most importantly, it prevents loss of functional capacity and dependence.MethodsThe dHOPE study is a three-armed, open-labelled, parallel-group randomized controlled trial (RCT) with non-inferiority design to compare a digital home-based prehabilitation program with a hospital-based program or no organized prehabilitation. In addition, the dHOPE study aims to identify measurable parameters reflecting the effect of prehabilitation, thus preparing for future personalization of the prehabilitation programs.DiscussionThe feasibility of multimodal prehabilitation is threatened by low compliance to hospital-based programs due to burdensome commuting, even in central and metropolitan areas. In sparsely populated countries, this challenge is even more pronounced. To ensure equal healthcare to all citizens regardless of address or economic situation, there is a need to transfer the prehabilitation program to the patients’ homes. Thus, the primary hypothesis of dHOPE is that a digital home-based program is not inferior to a hospital-based program. Moreover, given the patient diversity, prehabilitation must be personalized to meet individual profiles or needs. An exploratory subtask of dHOPE is to confirm the utility of clinical, genetic, and molecular factors in evaluating prehabilitation response ultimately to identify new biomarkers and develop medical software for individual risk stratification and development of personalized prehabilitation programs.
Clinical Trial registrationhttps://clinicaltrials.gov/, identifier (NCT06231576).