Digital Home-Based Prehabilitation Before Surgery (dHOPE)

Vestre Viken Hospital Trust

Status: Not yet enrolling

Conditions: Surgery; Frailty; Cancer Colorectal

Treatments: Other: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06231576

23/08551

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

Hospital

Experimental group

Description:

Prehabilitation at the hospital, with guidance by a dedicated physiotherapist physically present.

Treatment:

Other: Prehabilitation

Digital

Experimental group

Description:

Prehabilitation at home, with guidance from a dedicated physiotherapist through a digital platform, realtime.

Treatment:

Other: Prehabilitation

Control

No Intervention group

Description:

Information about the general benefit of a healthy lifestyle at inclusion, thereafter no further follow-up prior to surgery.