Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03564171 |
| Other study ID # |
041-2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2018 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
