A Randomized Controlled Feasibility Study Comparing a Multimodal Prehabilitation Protocol to Normal Care for Women Undergoing Neo-adjuvant Chemotherapy for Breast Cancer

Proposal: A randomized controlled feasibility study comparing a multi-modal prehabilitation protocol to usual care for women undergoing neo-adjuvant therapy for breast cancer.

Methods: Study population: Sixty patients who are undergoing curative intent neo-adjuvant chemotherapy for breast cancer will be randomized to intervention (n=30) or standard care (n=30) at a single site (Sunnybrook).

Intervention: A multi-modal program composed of an exercise prescription that will progressively increase in intensity and duration towards the current physical activity guidelines, nutritional counseling, stress counseling, and smoking cessation (as needed).

Intervention: Exercises will be instructed and demonstrated by a physiotherapist prior to the initiation of chemotherapy and will continue up until surgery. Nutritional and stress counseling, as well as smoking cessation, will be offered at initial consult with physiotherapist.

Exercise Protocol: The prehabilitation program entails a home-based exercise with both total-body physical exercise and exercises specific to the upper quadrant over the period between baseline assessment and surgery. The exercise prescription will be provided by a physiotherapist based upon the baseline assessment and will consist of a goal of 60 minutes of home-based, unsupervised exercise on 4 days per week, including aerobic and resistance training. Each session will be individualized and based upon the baseline assessment and generally include: a 5-minute warm-up, 25 minutes of moderate intensity aerobic exercise (for example: brisk walking, treadmill, stationary bike) (intensity of 3-6 on the 0-10 Rating of Perceived Exertion Scale) (attached, Appendix A) and 25 minutes of upper quadrant-specific training (Appendix B), and a 5-minute cool-down consisting of stretches (Appendix B). The program introduction will include a description and demonstration of all of the exercises that will follow the baseline assessment. The participant will have an opportunity to try the exercises in the presence of the physiotherapist who will provide corrective feedback if necessary. The physiotherapist will discuss safety precautions (posture, breathing, etc.) and provide the participant with an exercise manual that describes the exercises in the program and the safety precautions. To complete the exercises at home, each participant will be provided with resistance Theraband(s) (red and yellow) required to complete the upper quadrant exercises that they may keep at the end of the study. Training intensity progression will occur when the participant can complete the aerobic exercise with mild exertion and/or when the participant can complete 15 repetitions of a given upper quadrant exercise without eliciting at least moderate exertion (i.e. 3 to 6 on the Rating of Perceived Exertion scale). The prehabilitation program will be supported with a manual including institutionally created postoperative rehabilitation exercises that comprise a significant proportion of the preoperative exercise prescription. The physiotherapist will communicate with the participants every 2 weeks to ensure program compliance, support appropriate progression, and to address any barriers to exercise (including questions about appropriate exercise completion) that may prevent ongoing participation (see contact with team Table 1).