None listed
Conditions
Brief summary
The purpose of this study is to determine if a multimodal (exercise, nutrition and nursings support) prehabilitation program for patient undergoing major gastrointestinal cancer surgery for curative intent can be built into routine care. Who is it for? Patients with stage I-III or limited stage IV colorectal or upper gastrointestinal cancer undergoing curative intent surgery at concord repatriation general hospital. Study Details The study will involve both an exercise and diet program 2-4 weeks prior to major gastrointestinal surgery. All participants will receive the intervention. 1.Exercise: The exercise component will involve supervised and tailored 60-minute group-based exercise sessions per week using a combination of resistance and aerobic exercises delivered by an accredited exercise physiologist. In addition, 3 x homebased exercise training. 2. Nutrition: The nutritional component will involve Oral high protein supplements (Fresubin® Protein Energy) containing 20g protein, recommended to be consumed daily within one-hour post exercise to capitalize on muscle synthesis (day one until two days prior to surgery). In addition, nutritional advice will be provided delivered by a dietitian to achieve adequate oral protein intake. 3.Nursing support: One (15-20 minute) nurse-led phone support session per week of intervention Assessment Involvement in the study will involve a variety of body measurements and questionnaires, including questions about quality of life and patient satisfaction. It is hoped this study will further insight into how prehabilitation can decrease length of stay, lead to better surgical outcomes, whilst evaluating the change in functional, nutritional and psychological status.
Interventions
The intervention will commence from time of preadmission clinic assessment or direct screening from the surgeon’s rooms, allowing for a duration of 2-4 weeks. The prehabilitation intervention will consist of 1. Exercise: Consisting of one-two supervised, tailored 60-minute group-based exercise sessions per week delivered by an accredited exercise physiologist at the Survivorship Gym, Concord Hospital. Exercise sessions will be a combination of aerobic (AET) and resistance (RET) exercise training ranging from low, moderate to vigorous intensity. AET may include the use of a cycle ergometer, treadmill, elliptical and/or rowing machine. Target intensity of AET is 60-75% of heart rate reserve. Selection of apparatus will be dependent on participant preference and capability. RET will be of large muscle groups and use body weight, hand weights and/or cable machine exercises, e.g. bicep curls, shoulder press, bench press, push ups and sit-ups. Heart rate and Rating of Perceived Exertion (RPE) will be recorded throughout each session along with the intensity. Attendance to the exercise sessions will be recorded. Participants will be advised to participate in a home-based AET program tailored to their baseline ability. The target is to walk, cycle, and/or swim (dependent on preference) on (at least) three other days per week and to increase each bout of exercise to build up to a total of 30 minutes of home-based aerobic exercise (walking/cycling/swimming etc) on at least three days/week prior to their surgery. Participants will be provided with an exercise diary to capture the duration, intensity and type of activity. 2. Nutrition: Nutrition assessment and dietary advice (1 x 60 minutes total) will be provided by an accredited practicing dietitian at baseline. Dietary advice will be given focusing on meeting protein requirements (1.2-1.5g/kg per body weight or adjusted body weight in obese patients as per ESPEN guidelines) using food models and an inhouse developed written resource about healthy eating and protein foods. Patients who have additional dietary support needs (i.e. nutrition-related symptoms: bowels, nausea, loss of appetite; malnutrition), will have further individualised nutrition care plans and education as determined by the dietitian and/or their clinical team. Adherence to the dietary information will be measured using a 3-day food record for 2 weekdays and 1 weekend day, completed prior to commencing the intervention and repeated before the pre-surgical assessment. Participants were required to measure and record the quantity of all foods and beverages consumed, using standard household measures. Participants will be provided with oral high protein nutritional supplements (Fresubin® Protein Energy Drink 200ml) containing 20g protein and 300kcal, and recommended to be consumed daily within one-hour post exercise to capitalise on muscle synthesis (anabolic window), from day 1 until two days prior to surgery. Supplement intake and timing after exercise will be recorded in the patient diary and any unconsumed oral high protein supplements returned to monitor adherence. 3. Nursing support: One (15-20 minute) nurse-led phone support session per week of interventio Interventions are delivered face-to-face or via telehealth. In response to the COVID 19 pandemic, in March 2020 the program was adapted to include the use of telehealth/videoconferencing. This included joint exercise and nutrition assessments and exercise sessions delivered over videoconferencing.
Sponsors
Study design
Eligibility
Inclusion criteria
• Aged at least 18 years. • Pre-operative clinical staging confirmed stage I-III colorectal or upper GI cancer, or limited stage IV CRC (e.g. limited liver metastases planned for resection) or upper GI cancer that is potentially curable with surgery. • Elective colorectal cancer or upper gastrointestinal resection scheduled greater than 14 days after time of referral to study. • Medical clearance for exercise. • Willing to attend supervised exercise sessions 1-2 per week until surgery. • European Co-operative Oncology Group (ECOG)26 performance status of 0-2. • Willing to complete patient-reported outcome questionnaires and exercise/dietary logs. • Willing to take prescribed high protein supplements until surgery. • Agreeable to follow up for 30-days post-surgery.
Exclusion criteria
• Unable to do exercise or take nutritional supplement for physical or medical reasons. • Unable to give informed consent or follow instructions due to cognitive difficulties. • Currently undergoing neoadjuvant chemotherapy or radiotherapy. (Patients will be eligible for participation on completion of neoadjuvant chemo/radiotherapy providing there is at least 14 days before surgery).