Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Diakonhjemmet Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital | Experimental | Prehabilitation at the hospital, with guidance by a dedicated physiotherapist physically present. |
|
| Digital | Experimental | Prehabilitation at home, with guidance from a dedicated physiotherapist through a digital platform, realtime. |
|
| Control | No Intervention | Information about the general benefit of a healthy lifestyle at inclusion, thereafter no further follow-up prior to surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6MWT | Distance (in meters) walked in 6 minutes | At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| DNA methylation | 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. | At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery |
| RNA methylation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Rune Ougland, MD PhD | Vestre Viken, Bærum Hospital, Norway | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41132395 | Derived | 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. |
Not provided
Not provided
Protocol and SAP will be published together with results from the pilot study
By end of 2024
Upon request
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2024 | Jan 26, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D000073496 | Frailty |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery |
| 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. | At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery |
| Mortality | 90-day mortality | 3 months after surgery |
| 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) | 3 months after surgery |
| Need of additional health care support | Use of health care support from the municipality, nursing homes etc | 4-6 weeks after surgery |
| Aggregated length-of-stay (aLoS) | Total time in hospital (from surgery and any readmittance) within 30-days from surgery | 4-6 weeks after surgery |
| 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 | 3 months 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. |
| At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery |
| Metabolome | Blood samples for metabolome profiling will be implemented in a machine learning algorithm to search for biomarkers reliably reflecting frailty and effect of prehabilitation. | At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |