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Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.
Fit for surgery is a randomized clinical trial of multimodal prehabilitation prior to colon or rectal cancer surgery. Participants will either receive
The study is a part of the PREHAB study which is performed in collaboration with international centers.
The full protocol are published BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | Patients receive multi-modal prehabilitation with exercise three times weekly, protein supplements, vitamin supplements, dietitian consultation and medical optimization prior to surgery. A minimum of four weeks. |
|
| Standard of Care | No Intervention | Receives standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Other | A minimum of four weeks of prehabilitation with exercise three times a week, protein and vitamin supplements, dietitian consultation and medical optimization prior to surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery 15 | Difference in postoperative recovery between baseline and within 3 days after surgery. The cumulative score ranges from 0-150, with a higher value indicating a better outcome | 3 days after surgery |
| Changes in physical fitness prior to surgery | Changes in VO2 max between baseline and prior to surgery | Baseline, prior to surgery and 30 days after surgery |
| Complications | Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome. | 30 days after surgery |
| Changes in immunological function | Changes in immunological function measured by nanostring in blood and tumor (in the invasive front) | Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen |
| Measure | Description | Time Frame |
|---|---|---|
| Disease specific quality of life - EORTC c30 | European Organisation for Research and Treatment of Cancer Questionaire c 30 (EORTC c30). The EORTC c30 contains 6 domains which will each be assessed for mean changes in their cumulative score. The domains are physical function, role function, emotional function, pain, fatigue and global health. A higher value indicating a worse outcome | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Recruiting | Køge | Danmark | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38060453 | Derived | Bojesen RD, Dalton SO, Skou ST, Jorgensen LB, Walker LR, Eriksen JR, Grube C, Justesen TF, Johansen C, Slooter G, Carli F, Gogenur I. Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial. BJS Open. 2023 Nov 1;7(6):zrad134. doi: 10.1093/bjsopen/zrad134. | |
| 37162250 |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D000073496 | Frailty |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Randomized Clinical Trial with an intervention arm and a standard of care arm.
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Due to the nature of the interventions neither participant, care provider or investigator is blinded. Outcome assessor of primary outcomes are blinded.
| Disease specfic quality of life - EORTC c29 | European Organisation for Research and Treatment of Cancer Questionaire c 29 (EORTC). The questionnaire contains 29 items, with a 4 point Likert scale for symptoms and 7 point Likert scale for quality of life and global health. For the 4 point Likert scale the higher the score the worse the outcome. For the 7 point likert scale higher values indicating a better outcome. Analysis will be performed for changes in individual symptoms and cumulative aggregation of scores will not be performed. | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery |
| Overall quality of life - SF-36 | Short Form 36 question (SF-36) health questionnaire. The questionnaire contains eight domains: physical functioning, pain, limitations due to physical health problems, limitations due to personal or emotional problems, emotional well-being, social functioning, fatigue, and general health perceptions. Scores for each domain range from 0 to 100 and the analysis will be performed as mean difference between baseline and the following time frame. A higher value indicating a better outcome. | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery |
| Psychological health - Depression - PHQ-9 | Patient Health Questionnaire 9 (PHQ-9) Depression test. The PHQ-9 have a maximum of 27 points and a minimum of 0. The outcome is point change between baseline and following time frame. A higher value indicating a worse outcome | the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery |
| Psychological health - General anxiety - GAD-7 | General Anxiety Disorder 7-item (GAD-7). The questionnaire have a maximum of 21 points and a minium of 0. The outcome is the point change between baselin and the following time frame. A higher value indicating a worse outcome | the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery |
| Physical function (6-MWT) | 6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters | The day prior to surgery, 30 days after surgery, and 60 days after surgery |
| Physical function (STS) | Sit-to-stand test. Test of how many times the patient can rise from a chair in 30 seconds. | The day prior to surgery, 30 days after surgery, and 60 days after surgery. |
| Physical function (Stair climb test) | Stair climb test will be measured as the number of steps (17 mc in height) the paitent can rise in 30 secounds. | The day prior to surgery, 30 days after surgery, and 60 days after surgery |
| Physical function (Leg extension test) | Leg extension test will be measured by fixed dynaometer in newtons three times on each leg and the maximum for each leg used for analysis. | The day prior to surgery, 30 days after surgery, and 60 days after surgery |
| Physical function (Hand grip strength) | Hand grip strength measured by hand-held dynanometer in kilograms. Measured 3 times on each hand and will use the maximum obtained. | The day prior to surgery, 30 days after surgery, and 60 days after surgery |
| Nutritional status | Increase/decrease in total body weight in percent. | The day prior to surgery, 30 days after surgery, and 60 days after surgery |
| Remission and cancer free survival | Remission and cancer free survival | 5 years |
| Slagelse Hospital | Recruiting | Slagelse | Danmark | 4200 | Denmark |
|
| Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3. |
| 35588252 | Derived | Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2. |
| 35063042 | Derived | Bojesen RD, Jorgensen LB, Grube C, Skou ST, Johansen C, Dalton SO, Gogenur I. Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Pilot Feasibility Stud. 2022 Jan 21;8(1):11. doi: 10.1186/s40814-022-00967-8. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| 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 |