Health TrialsbyHealthPanel

Trimodal Prehabilitation in Colorectal Cancer Patients

ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJordan Leitch

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18 or older

major colorectal surgery (colectomy, low anterior resection or abdominoperineal resection)

Disqualifiers

refusal to participate in study

inability to understand questionnaires and participate in psychological assessments in English

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise

    Behavioral

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

  • Nutrition

    Dietary supplement

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

  • Mindfulness

    Behavioral

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Progress CheckOther 3 interventions
Group B: No Progress CheckOther 3 interventions

Trial outcomes

Primary outcomes

1

Retention rate

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

Time frame
Four to six weeks prior to surgery
2

Recruitment rate

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
3

Exercise completion rate

Percentage of strength exercises completed and percentage of aerobic exercise completed

Time frame
Four to six weeks prior to surgery
4

Nutrition compliance rate

Percentage of days protein shake was consumed

Time frame
Four to six weeks prior to surgery

Secondary outcomes

1

All-cause Mortality

Number of participants who died from any cause

Time frame
30 days after surgery
2

Readmission to hospital

Number of participants who were re-admitted to hospital

Time frame
30 days after surgery
3

Presentation to emergency department

Number of participants who presented to the emergency department

Time frame
30 days after surgery
4

Non-home discharge

Number of participants discharged to a non-home location

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jordan Leitch

Lead sponsor

Queen's University

Sponsor institution

Source ClinicalTrials.gov
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