Prehabilitation for Women Undergoing Pre-operative Chemotherapy for Breast Cancer
Condition: Breast Cancer; Rehabilitation; Neoadjuvant Therapy; Feasibility Studies
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess recruitment rate, attrition, compliance with weekly exercise, smoking cessation,
      and quality of life with a multimodal prehabilitation protocol for women with breast cancer
      undergoing neo-adjuvant chemotherapy for breast cancer.
    

Detailed description: 
      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).

      Grip Strength: Grip strength is commonly used to assess upper extremity strength in patients
      with breast cancer (Sagen 2009) and will be assessed via the "Jamar Hand" dynamometer
      according to established protocols.

      Aerobic Fitness: Aerobic fitness will be measured using the 6-minute walk test (6 Minute Walk
      Test). This test is a practical standardized measure of functional capacity and has been
      widely used for measuring the submaximal level of functional capacity in cancer patients
      (Vardar 2015, Santa Mina 2014, Schmidt 2013). This test will measure the distance that the
      patient can walk on a flat, hard surface in a period of 6 minutes.

      Nutrition counseling: The registered dietitian will provide an initial individualized
      nutrition assessment and counseling session. The consultation will be about 60 minutes in
      length and can be conducted in person or via telephone.

      The patient's nutritional history, assessment of usual intake and weight history will be
      reviewed to help identify any nutritional issues/concerns. The session will focus on the
      goals of nutrition before and during treatment, provide strategies to help the patient
      optimize or enhance the nutritional quality of the diet, maintain a healthy weight and
      minimize weight gain and address any nutrition-related questions or concerns.

      The registered dietitian will follow-up with the patient 4 weeks after the initial
      consultation to review the nutrition care goals and outcomes, answer questions re. any
      potential nutrition-related side effects from treatment and address any other questions or
      concerns.

      The patient will be encouraged to contact the dietitian as needed during treatment for
      on-going support of if any nutrition related questions or concerns.

      Stress counseling: Stress management intervention: Stress management intervention will
      consist of a 60-90 minute individual session with a psychiatrist specializing in psychosocial
      oncology. The therapy session will be cognitive-behavioral in orientation. The components
      will include a psychoeducational module on the stress response to physical symptoms;
      problem-solving and coping skills; relaxation techniques; and guided imagery. During the
      initial session, participants will be oriented conceptually to four types of interventions
      for reducing anxiety and coping with stress: (1) Progressive muscle relaxation; (2)
      mindfulness; (3) deep breathing; and (4) imagery/visualization. Each intervention will have
      accompanying written materials, which will also contain links to online audio materials. The
      additional materials contain written and spoken instructions allowing for self-directed
      learning and practice of each of the four stress-reducing interventions. Participants will be
      invited to choose one or two of the four strategies to practice with the therapist in the
      initial session, and in any subsequent sessions that participants attend. The therapist will
      instruct participants to choose one audio file to listen to at each chemotherapy session.

      Optional face-to-face 60 minute individual booster sessions will be offered to participants
      on a monthly basis until surgery, in order to review problem solving and coping skills,
      relaxation techniques, and guided imagery. If patients are found to need a greater frequency
      of psychiatric intervention or undergo a psychiatric crisis, or if they require psychotropic
      medications at any point during the study, the PI will be informed and a referral will be
      made to an alternate psychiatrist (if the patient chooses) at the Odette Cancer Centre who is
      not involved in this study.

      Every 2 weeks the patients in the intervention (prehabilitation arm) will be asked these
      questions:

      At each telephone follow-up or email, the frequency of use and acceptability will be assessed
      with the following questions:

      (1) Over the past two weeks, how often did you listen to one of the audio materials? Never
      Less than half the days More than half the days Once each day More than once per day

      (2a) During your most recent chemotherapy session, did you listen to any of the audio
      materials? Yes; No (2b) If no, please explain why _______________

      (3) In a general sense, how satisfied are you with the audio materials you have received?
      Very satisfied 5; Mostly satisfied 4; Indifferent 3; or mostly dissatisfied 2; Very
      dissatisfied 1

      At the end of the prehabilitation sessions, patients will fill in an 'acceptability of
      psychotherapy' evaluation (CSQ scale).

      Smoking cessation: If required. Sunnybrook has a comprehensive smoking cessation program in
      place. 16% of patients in the Odette Cancer Program are smokers (internal data). For those
      patients who identify as a smoker (answered "yes" to the question of "Have you used any forms
      of tobacco in the past 6 months?"), a brief smoking cessation intervention will be provided
      outlining the benefits of quitting as well as the impact of continued smoking on the
      treatments for cancer (chemotherapy, surgery and radiation). These patients will be given
      education on the use of nicotine replacement therapy and will be offered a redemption card
      for 4 boxes of free nicotine replacement therapy products of their choice and advised to
      speak with their pharmacist. Patients will also be encouraged to accept a referral to Smokers
      Helpline which provides free smoking cessation counseling (telephone, texting or web-based)
      with a Quit Coach.
    

Intervention name(s): Prehabilitation
Intervention type(s): Combination Product
Intervention description(s): stress counseling, exercise, nutritional counseling, smoking cessation counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arms: Intervention and Control (chosen by closed envelope, 1:1 randomization)
Masking: None (Open Label)
Primary purpose: Supportive Care