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Cancer ColorectaldHOPENCT06231576

Digital Home-Based Prehabilitation Before Surgery

A study testing Prehabilitation in people with Cancer Colorectal and Frailty, run by Vestre Viken Hospital Trust.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Colorectal, Frailty, Surgery
What is being tested?
Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
1 Feb 2024to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Planned for major gastrointestinal cancer surgery
  • Fluent in Norwegian and able to consent and to understand questionnaires

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Guro Kleve, MD contact

+47 32 80 30 00

guro.kleve@vestreviken.no

Rune Ougland, MD PhD contact

+47 32 80 30 00

rune.ougland@vestreviken.no

About this study

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.

Read the 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.

Being tested
Prehabilitation
Keywords
Prehabilitation, Colorectal cancer, Frailty
Medical subject headings
Colonic Neoplasms, Frailty, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrehabilitationOther

    • 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.
Study groups in NCT06231576
Study groupRoleWhat they receive
HospitalExperimentalPrehabilitation at the hospital, with guidance by a dedicated physiotherapist physically present.
Receives: Other: Prehabilitation
DigitalExperimentalPrehabilitation at home, with guidance from a dedicated physiotherapist through a digital platform, realtime.
Receives: Other: Prehabilitation
ControlNo interventionInformation about the general benefit of a healthy lifestyle at inclusion, thereafter no further follow-up prior to surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6MWT

    Distance (in meters) walked in 6 minutes

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

Secondary outcomes (8)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. Mortality

    90-day mortality

    Measured: 3 months after surgery

  5. 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)

    Measured: 3 months after surgery

  6. Need of additional health care support

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

    Measured: 4-6 weeks after surgery

  7. Aggregated length-of-stay (aLoS)

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

    Measured: 4-6 weeks after surgery

  8. 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

    Measured: 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231576
Sponsor's protocol ID
23/08551
Acronym
dHOPE
Status last verified
Jan 2024
First submitted
17 Nov 2023
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Protocol and SAP will be published together with results from the pilot study

Publications

  • Kleve G, Santa CD, Kristiansen F, Tegnander M, Buch V, Hagemann CS, Helgheim M, Engene P, Pesonen H, Kleveland MK, Hverven GL, Nilsen TS, Vervaart MAM, Aanesen H, Uglane KT, Bjelland M, Zory R, Chorin F, Cardot-Ruffino V, Beltran EEM, Neuzillet C, Soerensen M, Jylhava J, Anzar I, Normand VA, Myrstad M, Klungland A, Nilsen HL, Ougland R. Digital home-based multimodal prehabilitation of colorectal cancer patients prior to surgery (the dHOPE study): a non-inferiority clinical trial protocol. Front Digit Health. 2025 Oct 8;7:1609678. doi: 10.3389/fdgth.2025.1609678. eCollection 2025.

    PubMed 41132395

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation in people with Cancer Colorectal and Frailty, run by Vestre Viken Hospital Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guro Kleve, MD (+47 32 80 30 00, guro.kleve@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6MWT (time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231576, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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