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Impact of Mindfulness-based Trimodal Prehabilitation on functional recovery, nutritional status, biochemical markers and psychological markers of patients with colorectal cancer admitted to the Surgical Professorial unit of Colombo South Teaching Hospital, Sri Lanka - A randomized controlled trial

ABSTRACT: Interventions: Study setting- The study will be conducted at the Surgical Professorial Unit of Colombo South Teaching Hospital. Method of randomization- • Following consent, participants will be randomized 1:1 using a random number table to the intervention group or control group with stratification by gender and age group. •The research associate (who will be responsible for patient consent) will be blinded to group allocation. Description of mindfulness based tromodal prehabilitation intervention • The multidisciplinary Mindfulnes-Based trimodal prehabilitation program is composed of four (04) elements: 1. Exercise program 2. Nutritional intervention 3. Psychological coping 4. Mindfulness Protocol • The exact interventions are described in detail below: Exercise program • Patients will be asked to perform unsupervised exercises 4 days a week for 30 minutes per session. • The exercise regime will comprise of 5 min warm-up exercises, 20 min aerobic exercises and 5 min cool down exercises. • A personalized trainer will evaluate the patient and after discussing with the patient and their families will come up with an individualized exercise plan for the patients based on their physical capacity and resources. • They will also be given a DVD containing videos of the exercises performed by a trained personal giving instruction to the patient to follow. • Patients will be given a chart to fill once completing their exercise regime daily. Nutrition intervention • The patients enrolled in the prehabilitation program will be evaluated by a qualified nutritionist during the first visit, Aasubjective global assessment will be used to assess each patients’ nutritional status and requirements and an appropr Primary outcome(s): Functional recovery using the Six-Minute Walk Test (6MWT, Pulse Rate (PR), Blood Pressure (BP) and Oxygen Saturation (SpO2) [1. At the start of the trial 2. Four weeks after prehabilitation or Before the surgery 3. 4-Weeks post-operatively 4. 8-Weeks post-operatively ] Study Design: Randomized controlled trial

DISEASE(S): Colorectal Cancer

PROVIDER: 2564905 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Eligible participants will be prescribed an exercise program for a period of six weeks or up until surgery (whichever is earlier). Exercise prescriptions will be individualized to a participant’s prior aerobic fitness, medical comorbidities, response to any prior treatment and any immediate negative treatment effects of prior treatment (such as ongoing neuropathy and/or cancer cachexia) as per the ACSM Guidelines for exercise prescription. Exercise programs will be conducted one-on-one either in person in a hospital-based gym or unsupervised within the home environment based on the patient’s preference and ability to travel to the hospital. Exercise programs will be moderate to vigorous intensity as rated by the Borg RPE rating scale and prescribed in conjunction with cardiopulmonary exercise testing results. Exercise programs will include at least 3x30min aerobic exercise (walking/cycling/swimming) and 2x30min resistance sessions (upper and lower body strengthening exercises e.g. sit to stand, step ups, shoulder press) per week based on whether participants are meeting the ACSM exercise prescription guidelines at baseline. Participants will also be provided with a respiratory education session including information regarding breathing exercises to complete in the lead up to surgery. Given the complexity of this patient sample exercise prescription will also be adapted upon previous musculoskeletal injuries/issues (e.g. previous total joint replacements) and patients exercise preferences, to increase adherence with six-week program. Exercise programs will be progressed by a qualified physiotherapist and/or exercise physiologist based on participant’s response to exercise and compliance with the exercise program. The 30 min respiratory ed Primary outcome(s): Feasibility of delivering a six week individualized Exercise Prehabilitation Program amongst high risk surgical patients presenting for major cancer surgery. Feasibility of the program will be defined as: •Percentage of patients consenting to the exercise program = >70% consent rate •>70% adherence to exercise prescribed, as determined by participant exercise diaries •>85% retention in the study (Measures of non-compliance including dropout rates and reasons for drop out) •Intervention acceptability to patients •Cost of resources to run the study [Prior to surgery] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Type of endpoint: Safety/efficacy

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Impact of Mindfulness-based Trimodal Prehabilitation on functional recovery, nutritional status, biochemical markers and psychological markers of patients with colorectal cancer admitted to the Surgical Professorial unit of Colombo South Teaching Hospital, Sri Lanka - A randomized controlled trial

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