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Whey Protein

4-week multimodal preoperative intervention (i.e., Prehabilitation) consisting of an aerobic and strength training program, nutritional counselling and psychological support to help improve physical and psychological health prior to surgical resection of colorectal cancer.

This arm will receive a 4-week prehabilitation program consisting of:

Exercise: Participants will receive a 3x/week aerobic and strength training exercise program. They will perform 2 workouts per week at home and attend an in-hospital supervised exercise session once per week.

Nutritional counselling: Participants will meet with a registered dietician who will provide personalized nutritional recommendations and a whey protein supplement, tailored according to participants' self-reported dietary intake and anthropometric measurements.

Psychological support: Participants will receive a 90-minute session at baseline, and weekly in-hospital follow-ups throughout the preoperative period. The sessions will aim to reduce preoperative distress and improve adherence to the exercise program and nutritional recommendations. Psychological support will be delivered by a trained master's student, under the direct supervision of a registered Clinical Psychologist.

Multimodal prehabilitation

Franco Carli, MD

Psychological distress is common among adults newly diagnosed with cancer and those awaiting cancer treatment(s). Although preoperative psychological distress has been shown to be associated with poorer physical health and adverse treatments among colorectal cancer survivors, few psychological interventions have been developed to reduce distress, and improve physical health in the preoperative period. Moreover, whether a preoperative psychological intervention, delivered in addition to a multimodal Prehabilitation program can improve psychological and physical health remains unknown. Therefore, the purpose of this pilot cohort study was to examine the impact of a structured psychological intervention, given in addition to standard Prehabilitation, on preoperative psychological health and functional capacity in colorectal cancer patients awaiting surgery.

All participants will receive a multimodal prehabilitation program preoperatively for 4 weeks, composed of three elements: aerobic and strength training exercise program, nutritional counselling and psychological support. The exercise program will be three times per week and include a combination of home-based (twice per week) and supervised (once per week) sessions. Participants' nutritional status and dietary intake will be assessed by a registered dietician/nutritionist, and a whey protein supplement (Immunocal) will be prescribed to achieve a daily intake of 1.5 g protein/kg. Psychological support will consist of a 90-minute interview/session at baseline and weekly in-person follow-ups before surgery aimed at reducing psychological distress and improving adherence to the exercise program and nutritional recommendations. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.

Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection. Modalities to Mitigate the Level of Anxiety and Depression Prior to Surgery.

Change in participants' performance on the six-minute walk test (6MWT) across baseline (week 0), and post-intervention (week 4). The 6MWT measures the distance an individual can walk, in metres, in a 6-minute period. Greater distance walked during the 6MWT indicates greater functional capacity.

Postoperative complications (e.g., pneumonia, urinary tract infection, hemorrhage, bile leak) following colorectal resection will be measured and scored using the Clavien Classification. Each complication is graded between I ('Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy') to V ('Death of a patient') with higher grades indicating greater severity of complication.

Change in participants' self-reported anxiety and depressive symptoms across baseline (week 0), and post-intervention (week 4). Each item is scored on a 0 (e.g., 'Definitely as much') to 4 (e.g., 'Hardly at all') scale with higher scores representing greater severity of anxiety and depressive symptoms.

Change in participants' self-reported quality of life across baseline (week 0), and post-intervention (week 4). The SF-36 measures eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0-100 scale, with higher scores representing a more favourable health state.

Change in participants' self-reported physical activity levels across baseline (week 0), and post-intervention (week 4). CHAMPS measures the average number of hours individuals report engaging in 41 different activities (or varying intensities) during a typical week. Metabolic equivalent of task (MET) scores are calculated for activities engaged in at mild, moderate and vigorous intensity with higher scores indicating higher levels of engagement.

Change in participants' objective performance on the sit-to-stand test across baseline (week 0), and post-intervention (week 4). The sit-to-stand test measures lower body strength by recording the maximum number of times an individual can go from a seated position to a standing position, without using their arms, in a 30-second period.

Change in nutritional status across baseline (week 0), and post-intervention (week 4). Body mass index (kg/m2), lean body mass and percentage of body fat will be measured using a bioimpedance machine. Self-reported body weight loss in the preceding three months will be recorded. Serum albumin will be measured via blood draw.

McGill University Health Centre/Research Institute of the McGill University Health Centre

Patients will participate in a two-pronged prehabilitation strategy - physical prehabilitation and psychological prehabilitation. Prehabilitation will last from a minimum of 21 days to a maximum of 42 days before a patient's clinically indicated surgery.

No specific exercises or stress reduction techniques are prescribed and the patient will be counseled to continue their current level of activity, and will be given the information on exercise as outlined in the Cancer Care Ontario guidelines. Patients in the Usual Care arm will also be given the same Fitbit activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself and to be able to track the activity (steps) for comparison. Patients in the Usual Care arm will be required to wear their Fitbit activity tracker from the day of randomization to 90 days post-surgery. Patients will record their steps in the diary provided.

Physical prehabilitation will comprise a personalized, home-based exercise program designed to meet the Cancer Care Ontario Exercise Guidelines for Cancer Survivors. A Registered Kinesiologist (RKin) will complete a baseline physical assessment and prescribe an individualized multi-modal exercise program consisting of 4-5 days of 30+ minutes of aerobic exercise (brisk walking or equivalent to target heart rate of 40-60% of max) and 2-3 days of moderate intensity resistance training of major muscle groups (8-10 repetitions). Participants will be provided with a Fitbit with a heart rate monitor, resistance bands, and a stability ball. Patients will be required to wear their Fitbit and record the number of steps at the end of each day from randomization to 90 days post-surgery.

Physical Prehabilitation

Psychological prehabilitation will consist of one in-person coaching session of a 'mindfulness' informed intervention conducted by a specially trained RKin. The 40 minute coaching session will include a guided mindfulness session and debriefing. Participants will be asked to practice for 20 minutes twice a day. The patients will be given access to an audio file that will walk them through the 20 minute sessions.

Psychological Prehabilitation

Emily Taylor

Rachel Aitken

Anand Govindarajan, MD, MSc

Anand Govindarajan, MD MSc

This is a randomized control trial aiming to investigate the use of a prehabilitation regimen for patients undergoing major GI cancer surgery and its effects on measurements of HRQOL, LOS, and post-operative complications. Participants will be randomized to either the Prehabilitation arm or the Usual Care arm (control group). The Prehabilitation arm will be prescribed both physical and psychological prehabilitation prior to undergoing surgery for their GI cancer. The Usual Care arm will be counseled to continue their current level of activity and given the information on exercise as outlined in the Cancer Care Ontario guidelines. Participants in the Usual Care arm will also be given the same activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself. Clinical, patient-reported outcomes and health system outcomes will be evaluated. Outcomes will be measured at consent (baseline), immediately preoperatively, and postoperatively at 1, 3 and 6 months. The investigators will collect measures of recruitment, attrition and self-reported compliance via a log completed by the coordinator during weekly patient phone calls.

Prehabilitation to Improve Cancer Surgery Outcomes

Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO): A Randomized Controlled Trial

The primary outcome is the difference between the baseline and 90-day global health score on the European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30

The presence and severity of postoperative complications at 30 and 90 days will be recorded from the patient's medical records

The patient's postoperative length of stay will be recorded from the medical records

Patients will perform a 6-Minute Walk Test.

Changes in self-reported physical activity will be measured using the Godin Leisure-time Exercise Questionnaire

HRQOL will be measured using the EQ-5D Health Questionnaire

The presence and severity of nine common symptoms in cancer patients will be examined using the Edmonton Symptom Assessment Scale (ESAS). This self-report measure examines: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath.

Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale (HADS). HADS assesses anxiety and depression through self-reporting based on the frequency of symptoms over the past week. There are 2 subscales, one for anxiety and for depression, each with 7 items. Items are scored on a 4 point Likert scale (0-3), with the subscale scores being sums of each item (0-21). A higher score is indicative of higher or worse anxiety and depression.

Changes in cancer-specific fatigue will be assessed using the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).

The degree to which the patient's health problems interfere with occupational performance and productivity will be examined using the Work Limitations Questionnaire

Changes in the perceived availability of multidimensional social support will be evaluated using the Medical Outcomes Study Social Support Scale (MOS-SSS SF-20). The MOS-SSS SF-20 is a 20 item questionnaire that measures physical functioning, social functioning, mental health, current health perceptions, and pain. After reverse scoring of the appropriate items according to the MOS-SSS core scoring manual, a higher value indicates better functioning, health, and more pain in the respective measures. All measure scores are transformed linearly to scales from 0-100, with 100 being the highest score possible.

The Experiences in Close Relationships Scale (ECR M16) will be used to examine adult attachment or closeness in both romantic and non-romantic relationships. There are two domains that are measured - attachment anxiety and avoidance. Each domain includes 8 items. Items are scored on a 7 point Likert Scale (1-7). After appropriate reverse scoring, a high score indicates higher attachment anxiety or avoidance.

Health care utilization will be assessed at the postoperative 3 and 6 month time points using the Health Service Utilization Inventory

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.	NCT04248647	Colorectal Canc...	Multimodal preh...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Prehabilitation to Improve Cancer Surgery Outcomes	NCT03502317	Gastrointestina... Prehabilitation Surgery Physical Activi...	Physical Prehab... Psychological P...	18 Years -	Mount Sinai Hospital, Canada

Spots Global Cancer Trial Database for psychological prehabilitation