Clinical trial NCT06231576: Digital Home-Based Prehabilitation Before Surgery
Official title: Digital Home-Based Prehabilitation Before Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Colorectal
Frailty
Surgery
Keywords: Prehabilitation
Colorectal cancer
Frailty
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Diakonhjemmet Hospital
First posted: 2024-01-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.

Detailed description: Patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. The eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in Norwegian able to consent and to understand questionnaires. The main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. In addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. Participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. The control group will receive no organized prehabilitation in the period of time between diagnose and surgery.

Eligibility criteria: Inclusion Criteria:

* Planned for major gastrointestinal cancer surgery
* Fluent in Norwegian and able to consent and to understand questionnaires

Exclusion Criteria:

* Inability to walk for six minutes or to rise independently from a chair
* Inability to comprehend exercise program or to comply with written and oral instructions
* Presence of a cardio-pulmonary condition that precludes exercise
* Living in very remote areas making a hospital-based intervention group impossible to implement
* Being without a permanent address
* Admittance to a hospital facility for \> 50% of the time from diagnosis to surgery

Primary outcomes:
measure: 6MWT
timeFrame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Secondary outcomes:
measure: EuroQol Group Questionnaire 5D (EQ-5D)
timeFrame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
measure: European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire
timeFrame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
measure: Generic Short Patient Experiences Questionnaire (GS-PEQ)
timeFrame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
measure: Mortality
timeFrame: 3 months after surgery
measure: Complications
timeFrame: 3 months after surgery
measure: Need of additional health care support
timeFrame: 4-6 weeks after surgery
measure: Aggregated length-of-stay (aLoS)
timeFrame: 4-6 weeks after surgery
measure: Cost-effectiveness
timeFrame: 3 months after surgery
Other outcomes:
measure: DNA methylation
timeFrame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
measure: RNA methylation
timeFrame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
measure: Metabolome
timeFrame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Locations:
Study officials:
affiliation: Vestre Viken, Bærum Hospital, Norway
name: Rune Ougland, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: