Digital Home-Based Prehabilitation Before Surgery

Surgery Clinical Trial

— dHOPE  

Official title:

Digital Home-Based Prehabilitation Before Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06231576
• Other study ID #: 23/08551
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2024
• Source: Vestre Viken Hospital Trust
• Contact: Guro Kleve, MD
• Phone: +47 32 80 30 00
• Email: guro.kleve[@]vestreviken.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Colorectal
• Frailty
• Surgery

Intervention

Other:
• Prehabilitation
Nutritional optimization: A nutritionist will perform a structured interview, comprehensive nutrition assessment, and provide personalized dietary advice. The main goal is to ensure optimal protein intake to support exercise-induced anabolism. A daily protein intake of 1.2-2.0 g/kg will meet needs as outlined in surgical nutrition guidelines. Exercise: Based on current guidelines and instructed by a dedicated physiotherapist, for 1 hour per day preoperatively to increase muscle strength, aerobic capacity and physical endurance. Intensity will be based on the rate of perceived exertion using the Borg scale, a 15-graded scale ranging from very light to very hard. Resistance exercises will target upper/lower body, and abdominal muscles. Psychological coaching and support: Performed as one interview during inclusion, followed by weekly phone calls by a study nurse coordinator during the preoperative intervention.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Diakonhjemmet Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DNA methylation	Blood samples for DNA methylation profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation.	At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Other	RNA methylation	Blood samples for RNA methylation profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation.	At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Other	Metabolome	Blood samples for metabolome profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation.	At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Primary	6MWT	Distance (in meters) walked in 6 minutes	At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Secondary	EuroQol Group Questionnaire 5D (EQ-5D)	EQ-5D is a standardized measure of health-related quality of life with 5 dimensions, each dimension represented by a value 1-5 where higher value represents worse outcome.	At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Secondary	European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire	The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Secondary	Generic Short Patient Experiences Questionnaire (GS-PEQ)	GS-PEQ is a questionnaire for collecting data about user experiences across different types of services. The questionnaire has 12 questions ranging from 1-5; a higher score represents a higher ("better") experience.	At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Secondary	Mortality	90-day mortality	3 months after surgery
Secondary	Complications	Comprehensive Complication Index (CCI) reflects the gravity of the overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)	3 months after surgery
Secondary	Need of additional health care support	Use of health care support from the municipality, nursing homes etc	4-6 weeks after surgery
Secondary	Aggregated length-of-stay (aLoS)	Total time in hospital (from surgery and any readmittance) within 30-days from surgery	4-6 weeks after surgery
Secondary	Cost-effectiveness	An estimation of the resources used on the prehabilitation program will be compared to resources saved by shorter aLoS, less use of nursing home facilities and less need of community healthcare services	3 months after surgery