Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231576
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-11-17
Brief Title:
Digital Home-Based Prehabilitation Before Surgery
Sponsor:
Vestre Viken Hospital Trust
Organization:
Vestre Viken Hospital Trust
Study Overview
Official Title:
Digital Home-Based Prehabilitation Before Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
dHOPE
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None