Digital Home-Based Prehabilitation Before Surgery (dHOPE)

V

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)

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.

Trial documents
1

Trial contacts and locations

0

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Central trial contact

Rune Ougland, MD PhD; Guro Kleve, MD

Data sourced from clinicaltrials.gov

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