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NCT Number: NCT06231576

Digital Home-Based Prehabilitation Before Surgery

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.

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Key information

Conditions

Cancer Colorectal Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Frailty Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Other
  • 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.

Primary outcomes

  1. 6MWT

    Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

    Distance (in meters) walked in 6 minutes

Secondary outcomes

  1. EuroQol Group Questionnaire 5D (EQ-5D)

    Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

    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.

  2. European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire

    Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

    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.

  3. Generic Short Patient Experiences Questionnaire (GS-PEQ)

    Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

    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.

  4. Mortality

    Time frame: 3 months after surgery

    90-day mortality

  5. Complications

    Time frame: 3 months after surgery

    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)

  6. Need of additional health care support

    Time frame: 4-6 weeks after surgery

    Use of health care support from the municipality, nursing homes etc

  7. Aggregated length-of-stay (aLoS)

    Time frame: 4-6 weeks after surgery

    Total time in hospital (from surgery and any readmittance) within 30-days from surgery

  8. Cost-effectiveness

    Time frame: 3 months after surgery

    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

Other outcomes

  1. DNA methylation

    Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

    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.

  2. RNA methylation

    Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

    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.

  3. Metabolome

    Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery

    Blood samples for metabolome profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation.

Study contacts

Contact information is provided by the study sponsor or research team.

Guro Kleve, MD

CONTACT

[email protected]

+47 32 80 30 00

Rune Ougland, MD PhD

CONTACT

[email protected]

+47 32 80 30 00

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Diakonhjemmet Hospital

Registry information

Acronym: dHOPE

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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