Trimodal Prehabilitation in Colorectal Cancer Patients

NCT05880992 | Recruiting

• 1 other identifier: PrehabCRC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (6)

• Retention rate

  Rate of participants who completed entire duration of prehabilitation, regardless of components performed

  Four to six weeks prior to surgery

• 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

• Exercise completion rate

  Percentage of strength exercises completed and percentage of aerobic exercise completed

  Four to six weeks prior to surgery

• Nutrition compliance rate

  Percentage of days protein shake was consumed

  Four to six weeks prior to surgery

• Mindfulness compliance rate

  Percentage of deep breathing exercises performed

  Four to six weeks prior to surgery

• Adherence rate

  Percentage of all components of prehabilitation completed by participants

  Four to six weeks prior to surgery

Secondary Outcomes (5)

• All-cause Mortality

  30 days after surgery

• Readmission to hospital

  30 days after surgery

• Presentation to emergency department

  30 days after surgery

• Non-home discharge

  30 days after surgery

• Major complications

  30 days after surgery

Study Arms (2)

Progress Check

OTHER

This arm will include pre- and post-prehabilitation questionnaires as well as twice weekly progress checks by the research assistant to check on participant progress, answer questions and provide accountability and motivation.

Behavioral: Exercise; Dietary Supplement: Nutrition; Behavioral: Mindfulness

No Progress Check

OTHER

This arm will include only pre- and post-prehabilitation questionnaires.

Behavioral: Exercise; Dietary Supplement: Nutrition; Behavioral: Mindfulness

Interventions

Exercise BEHAVIORAL

Aerobic and Strength exercises (equipment free, simple, modifiable)

No Progress Check; Progress Check

Nutrition DIETARY_SUPPLEMENT

Counselling on daily protein target of 1.2 g/kg as well as supplementation with protein shake (provided)

No Progress Check; Progress Check

Mindfulness BEHAVIORAL

Deep (box) breathing completing in the morning, evening and as needed.

No Progress Check; Progress Check

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• major colorectal surgery (colectomy, low anterior resection or abdominoperineal resection)

You may not qualify if:

• refusal to participate in study
• inability to understand questionnaires and participate in psychological assessments in English

Sponsors & Collaborators

• Jordan Leitch: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K0H1S0, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 35063042 BACKGROUND

• 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.

  PMID: 35945625 BACKGROUND

• 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.

  PMID: 30025745 BACKGROUND

• 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.

  PMID: 23052535 BACKGROUND

• 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.

  PMID: 34851778 BACKGROUND

• 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.

  PMID: 30462375 BACKGROUND

• 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.

  PMID: 34922735 BACKGROUND

• 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.

  PMID: 35589429 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Exercise; Nutritional Status; Mindfulness

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jordan Leitch

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Leitch, MD

CONTACT

6134494223; Jordan.Leitch@Kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician, Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 30, 2023
• Study Start: July 24, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)