Colorectal Cancer Clinical Trial
— PrehabCRCOfficial title:
Trimodal Prehabilitation in Colorectal Cancer Patients: a Feasibility Pilot
NCT number | NCT05880992 |
Other study ID # | PrehabCRC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 24, 2023 |
Est. completion date | June 30, 2025 |
The goal of this clinical pilot is to determine the feasibility of implementing trimodal prehabilitation within the current perioperative infrastructure in patients having major colorectal surgery for resection of a cancer (CRC). Trimodal prehabilitation includes exercise, nutrition and mindfulness coaching and support which has been shown to improve physical status, mental preparation and to reduce loss of lean body mass in CRC patients. The primary questions this study aims to answer are: Is delivery of trimodal prehabilitation feasible within our current perioperative infrastructure and does prehabilitation impact outcomes in these patients? Researchers will compare this newly recruited prehabilitation cohort to a historical cohort of patients who did not receive prehabilitation in terms of mortality, length of stay, complications, readmissions, emergency department visits and non-home discharge.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age 18 or older - major colorectal surgery (colectomy, low anterior resection or abdominoperineal resection) Exclusion Criteria: - refusal to participate in study - inability to understand questionnaires and participate in psychological assessments in English |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Jordan Leitch |
Canada,
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. — View Citation
Chmelo J, Phillips AW, Greystoke A, Charman SJ, Avery L, Hallsworth K, Welford J, Cooper M, Sinclair RCF. A feasibility trial of prehabilitation before oesophagogastric cancer surgery using a multi-component home-based exercise programme: the ChemoFit study. Pilot Feasibility Stud. 2022 Aug 9;8(1):173. doi: 10.1186/s40814-022-01137-6. — View Citation
Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9. — View Citation
Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9. — View Citation
Martin D, Besson C, Pache B, Michel A, Geinoz S, Gremeaux-Bader V, Larcinese A, Benaim C, Kayser B, Demartines N, Hubner M. Feasibility of a prehabilitation program before major abdominal surgery: a pilot prospective study. J Int Med Res. 2021 Nov;49(11):3000605211060196. doi: 10.1177/03000605211060196. — View Citation
McAdams-DeMarco MA, Ying H, Van Pilsum Rasmussen S, Schrack J, Haugen CE, Chu NM, Gonzalez Fernandez M, Desai N, Walston JD, Segev DL. Prehabilitation prior to kidney transplantation: Results from a pilot study. Clin Transplant. 2019 Jan;33(1):e13450. doi: 10.1111/ctr.13450. Epub 2018 Dec 21. — View Citation
McIsaac DI, Gill M, Boland L, Hutton B, Branje K, Shaw J, Grudzinski AL, Barone N, Gillis C; Prehabilitation Knowledge Network. Prehabilitation in adult patients undergoing surgery: an umbrella review of systematic reviews. Br J Anaesth. 2022 Feb;128(2):244-257. doi: 10.1016/j.bja.2021.11.014. Epub 2021 Dec 16. — View Citation
McIsaac DI, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M. Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. Br J Anaesth. 2022 Jul;129(1):41-48. doi: 10.1016/j.bja.2022.04.006. Epub 2022 May 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retention rate | Rate of participants who completed entire duration of prehabilitation, regardless of components performed | Four to six weeks prior to surgery | |
Primary | Recruitment rate | Number of patients booked for surgery compared to the number of overall patients booked for surgery during the study timeframe. | Four to six weeks prior to surgery | |
Primary | Exercise completion rate | Percentage of strength exercises completed and percentage of aerobic exercise completed | Four to six weeks prior to surgery | |
Primary | Nutrition compliance rate | Percentage of days protein shake was consumed | Four to six weeks prior to surgery | |
Primary | Mindfulness compliance rate | Percentage of deep breathing exercises performed | Four to six weeks prior to surgery | |
Primary | Adherence rate | Percentage of all components of prehabilitation completed by participants | Four to six weeks prior to surgery | |
Secondary | All-cause Mortality | Number of participants who died from any cause | 30 days after surgery | |
Secondary | Readmission to hospital | Number of participants who were re-admitted to hospital | 30 days after surgery | |
Secondary | Presentation to emergency department | Number of participants who presented to the emergency department | 30 days after surgery | |
Secondary | Non-home discharge | Number of participants discharged to a non-home location | 30 days after surgery | |
Secondary | Major complications | Rate of surgical site infection and major bleeding | 30 days after surgery |
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