STUDY OVERVIEW

Who is Eligible for this Study?

This study aims to recruit 38-50 participants who have previously received a diagnosis of any subtype and disease stage of head and neck cancer, and have received any treatment type such as surgery, chemotherapy, radiation, or a combination of these treatment modalities.

Eligible participants are those who:

●  are at least 1-year post treatment for head and neck cancer;

●  have adequate shoulder range of motion;

●  have not engaged in resistance exercise in the past one month;

●  and are not currently participating in another exercise or pharmaceutical (drug) study

Once you have received a study invitation in the mail, please contact the study coordinator. Participation in this study is voluntary and choosing not to do so will not result in any consequences or impact your healthcare services. If you decide to participate, the study coordinator will schedule a pre-screening meeting to review medical history, obtain verbal consent, send the Baseline Questionnaires, and schedule your in-person baseline fitness assessment.

What Will Happen During the Study?

Assignment to a Group

If you decide to participate, then you will be randomized into one of two groups: the heavy lifting strength training group (exercise) or the usual care group (no exercise). Randomization means that you are put into a group completely by chance. We will ask half of the study participants to do a supervised exercise program, and the other half will be instructed not to exercise any more than their usual routine. Then, we will compare the physical and psychosocial results of both groups to see if heavy lifting strength training is better than no exercise for improving outcomes important to you or not.

Neither you, the research staff, or the researcher can choose which group you will be assigned to.

Study Intervention

Group 1 – Exercise Group (Experimental): Heavy Lifting Strength Training

You will be asked to complete a 12-week, supervised, heavy lifting strength training exercise program. This program will consist of two supervised exercise sessions per week. Each session will involve one Exercise Physiologist/Registered Kinesiologist supervising one or two participants at a time. Gradual progressions to lifting heavier loads at higher intensities will take place over a 5-week period. Each exercise session will last approximately one hour, consisting of a warm up, weight training and rest periods, and a cool-down. The three main exercises are as follows: barbell squat, bench press, and deadlift, and additional/accessory exercises will be included. The duration of the session may be longer or shorter for you than it will be for another person depending on exercise familiarity, exercise modifications, how you feel on any given day, and whether you require more or less rest between exercises. All supervised exercise sessions will take place in the Exercise Oncology Research Laboratory located in the Edmonton Clinic Health Academy (ECHA) at the University of Alberta and will be supervised by the study coordinator Stephanie Ntoukas; a Registered Kinesiologist, experienced lifter of heavy things, and 3-time pediatric and young adult head and neck cancer survivor.

Group 2 – Usual Care (Non-experimental): Control Group

Patients randomized to the usual care group will be instructed to continue with their usual daily activities, and they will not receive any specific information or education regarding exercise. However, they will be offered a 4-week introduction to heavy lifting strength training program and/or referred to a community-based exercise program after the postintervention assessments are complete. 

Study Procedures

The following established procedures will be done as part of this study. Some may be done more frequently than if you were not taking part in this study. Some of these procedures may be done solely for the purpose of the study. If the results show that you are not able to continue participating in the study, the study team will let you know.

●  Pre-Screening Meeting: The study coordinator, Stephanie Ntoukas, will arrange a 15-20 minute online or in-person meeting to confirm medical history such as type and stage (I-IV) of head and neck cancer, time since treatment, type of treatment (surgery, radiation therapy, chemotherapy, or a combination), current and past exercise history, preferred method of contact, and obtain verbal consent to continue with the recruitment process. This will also be an opportunity to ask questions and discuss concerns that you may have before in-person baseline physical assessments. Once the baseline assessment is booked, written consent will be obtained at the in-person baseline assessment. You will receive a hardcopy of the written consent form.

●  Resting values: blood pressure and heart rate will be monitored before and after exercise testing, and researchers will continue to ask how you feel at regular intervals throughout the tests.

●  Anthropometric measurements: To estimate general health risk, anthropometric measurements will include height, weight, and circumferences. Height and weight will be used to calculate body mass index. Circumference measurements will be taken of the waist and hips.

●  Body composition: To assess the distribution of the fat and muscle mass in your body. This assessment will take place at the Li-Ka Shing Centre for Health Research Innovation at the University of Alberta, a 5-8 minute walk from our facility. Here, a 60-second, bioelectrical impedance assessment will be conducted. This device does not emit radiation and consists of electrical currents passing through the body. This is a non-invasive assessment where you will be required to stand barefoot on a slightly elevated platform and hold on to two sensors for 60-seconds. Pregnant women or individuals with pacemakers will be exempt from this assessment. We know that strength training may alter body composition; increase muscle mass and reduce fat mass. The results of this assessment will be used to monitor any changes in body composition from the start to the end of the study.

●  Maximal strength exercise tests: To determine the maximal force that your muscles can exert to overcome the most resistance. These tests will consist of the machine-based leg press and chest press where you will be encouraged to increase the weight until you cannot lift it for more than three times. The researchers will monitor your blood pressure and heart rate before and after each session, and will ask you how hard you feel you are working throughout the test. The test results will also be used to provide an individualized/optimal exercise program based on your fitness levels at the start of the program.

●  Functional fitness tests: To determine your physical function, flexibility, and agility. Your functional fitness will be assessed through a series of small tests, including walking for 6 minutes, handgrip strength, and 30-second chair stands. Shoulder flexion and abduction ranges of motion will also be measured using a goniometer to assess for the ability to reach overhead. We are trying to determine if the exercise program is effective at improving physical function.

Questionnaires

●  The study includes a questionnaire package to assess outcomes related to head and neck cancer and its treatment, such as quality of life, fatigue, perceived stress, insomnia, exercise motivation and barriers.

●  All participants will be asked to answer the questionnaires at baseline and 12-weeks later, at the end of the study. The questionnaire package takes about 30-40 minutes to be completed.