Trimodal Prehabilitation in Colorectal Cancer Patients (PrehabCRC)
Primary Purpose
Colorectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Nutrition
Mindfulness
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Progress Check
No Progress Check
Arm Description
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.
This arm will include only pre- and post-prehabilitation questionnaires.
Outcomes
Primary Outcome Measures
Retention rate
Rate of participants who completed entire duration of prehabilitation, regardless of components performed
Recruitment rate
Number of patients booked for surgery compared to the number of overall patients booked for surgery during the study timeframe.
Exercise completion rate
Percentage of strength exercises completed and percentage of aerobic exercise completed
Nutrition compliance rate
Percentage of days protein shake was consumed
Mindfulness compliance rate
Percentage of deep breathing exercises performed
Adherence rate
Percentage of all components of prehabilitation completed by participants
Secondary Outcome Measures
All-cause Mortality
Number of participants who died from any cause
Readmission to hospital
Number of participants who were re-admitted to hospital
Presentation to emergency department
Number of participants who presented to the emergency department
Non-home discharge
Number of participants discharged to a non-home location
Major complications
Rate of surgical site infection and major bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05880992
Brief Title
Trimodal Prehabilitation in Colorectal Cancer Patients
Acronym
PrehabCRC
Official Title
Trimodal Prehabilitation in Colorectal Cancer Patients: a Feasibility Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 24, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jordan Leitch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Fifty patients aged 18 years or greater booked to undergo major colorectal surgery (colectomy, low anterior resection or abdominoperineal resection) will be enrolled from June to August 2023 from the colorectal cancer (CRC) clinic at Kingston Health Sciences Centre in Kingston, Ontario. The CRC nurse navigator will identify new CRC diagnoses coming into clinic and will alert the research team. A research assistant will attend the CRC clinic when potentially eligible patients are booked and will approach regarding recruitment into the study. Exclusion criteria will include refusal to participate in study and inability to understand questionnaires and participate in psychological assessments in English. Once recruited to study, the research assistant will give the patient the prehabilitation resources (including a prescription for aerobic and strength exercises to be completed each week, 36 Premier Protein shakes (30g protein, 150 calories per shake) and a handout describing deep breathing exercises) and arrange a time with the patient to complete baseline questionnaires and deliver prehabilitation consultation. The rationale for delaying this initial consultation is to prevent overwhelming patients with information after receiving a new cancer diagnosis. Patients will have a prehabilitation study consultation including completion of three questionnaires: self-assessment of physical activity (CHAMPS), nutritional screening (CNST) and health care related quality of life (SF-36). Patients will then be given all prehabilitation education and counselling.
Study patients will participate in a trimodal prehabilitation program (including exercise, nutrition and mindfulness goals) prior to surgery, and will be randomized into two groups: 1) Prehabilitation with twice-weekly progress checks (adherence to prehabilitation program) and 2) Prehabilitation without progress checks. Both groups of patients will complete daily activity trackers to document exercise completion, protein drink consumption and deep breathing exercises. One week prior to surgery, a research assistant will contact all participants and conduct CHAMPS, CNST and SF-36 as well as collect feasibility outcomes including weeks available for prehabilitation before surgery, satisfaction with prehabilitation program and adherence to program (participating in phone calls, completing exercises, daily protein shake (30g) and mindfulness exercise). Groups that are designated as including progress checks will be called by a research assistant twice per week to check in on progress regarding all components of prehabilitation program (adherence, compliance, issues).
An additional analysis will be performed comparing the 50 patients from this feasibility pilot (prehabilitation group) to the previous 50 patients booked for major colorectal surgery (standard care group) using existing data from the colorectal database. These groups will be assessed for secondary outcomes including mortality, length of stay, emergency department visits, readmissions, major complications and non-home discharge. This pilot study will guide the development of a larger study to assess the delivery of prehabilitation and rehabilitation after major colorectal surgery utilizing CloudDX, software that can be programmed to deliver reminders, surveys and important information to assist with adherence to the prehabilitation regimen. In addition, these future studies will utilize remote vital sign monitoring via CloudDX to collect important biometric data to richen the interpretation of the effects of prehabilitation on this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Progress Check
Arm Type
Other
Arm Description
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.
Arm Title
No Progress Check
Arm Type
Other
Arm Description
This arm will include only pre- and post-prehabilitation questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Aerobic and Strength exercises (equipment free, simple, modifiable)
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition
Intervention Description
Counselling on daily protein target of 1.2 g/kg as well as supplementation with protein shake (provided)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Deep (box) breathing completing in the morning, evening and as needed.
Primary Outcome Measure Information:
Title
Retention rate
Description
Rate of participants who completed entire duration of prehabilitation, regardless of components performed
Time Frame
Four to six weeks prior to surgery
Title
Recruitment rate
Description
Number of patients booked for surgery compared to the number of overall patients booked for surgery during the study timeframe.
Time Frame
Four to six weeks prior to surgery
Title
Exercise completion rate
Description
Percentage of strength exercises completed and percentage of aerobic exercise completed
Time Frame
Four to six weeks prior to surgery
Title
Nutrition compliance rate
Description
Percentage of days protein shake was consumed
Time Frame
Four to six weeks prior to surgery
Title
Mindfulness compliance rate
Description
Percentage of deep breathing exercises performed
Time Frame
Four to six weeks prior to surgery
Title
Adherence rate
Description
Percentage of all components of prehabilitation completed by participants
Time Frame
Four to six weeks prior to surgery
Secondary Outcome Measure Information:
Title
All-cause Mortality
Description
Number of participants who died from any cause
Time Frame
30 days after surgery
Title
Readmission to hospital
Description
Number of participants who were re-admitted to hospital
Time Frame
30 days after surgery
Title
Presentation to emergency department
Description
Number of participants who presented to the emergency department
Time Frame
30 days after surgery
Title
Non-home discharge
Description
Number of participants discharged to a non-home location
Time Frame
30 days after surgery
Title
Major complications
Description
Rate of surgical site infection and major bleeding
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Leitch, MD
Phone
6134494223
Email
Jordan.Leitch@Kingstonhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Leitch
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35063042
Citation
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.
Results Reference
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PubMed Identifier
35945625
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.
Results Reference
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PubMed Identifier
30025745
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
30462375
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Citation
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Results Reference
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Trimodal Prehabilitation in Colorectal Cancer Patients
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