An evidence-based intervention (“Fit for Treatment”) to ...



An evidence-based intervention (“Fit for Treatment”) to prevent chemotherapy-induced neurotoxicity in breast cancer patients: An effectiveness-implementation hybrid studyIntroduction and Purpose of this StudyResearch has shown that neurotoxicity (i.e. physical damage to the nervous system) can develop in individuals who undergo chemotherapy regimens, with common symptoms including numbness, tingling or pain in the fingers/toes, muscle weaknesses and balance difficulties. Chemotherapy regimens have also been linked with an increased risk of cardiovascular disease. Exercise has shown to be effective in improving these neurotoxic effects and cardiovascular function after treatment, yet its potential in preventing these health problems during treatment are still not known. Therefore, the purpose of this research study is to implement and evaluate a neurotoxicity-targeted intervention during breast cancer chemotherapy. We will also be looking at the potential impact of the exercise intervention on hospital resources, if we were to offer access to exercise programs like this for all women with breast cancer.Participation and WithdrawalYou have been provided with this information sheet as it has been determined by the team at the Metropolitan South Health Service, Division of Cancer Services, Princess Alexandra Hospital, that you are eligible for this study. Participation in this study is entirely voluntary. You are free to withdraw from the study at any time. Withdrawal from the study will not affect your current or future course of treatment. What does Participation in this Study Involve?If you agree and consent to being included in this study, you will be asked to perform baseline testing (further details provided below under “Testing Sessions”). Upon successfully completing this baseline testing, you will be randomly assigned to one of two groups, either an exercise intervention or control group. Randomisation means you are put into a group by chance. Neither you, your doctor, nor the study investigators choose or are aware of which group you will be placed in. You have an equal chance of being placed in either group. Intervention Group If you are randomised to the intervention group you will be invited to participate in a 12-week exercise intervention. Accredited Exercise Physiologists (AEP) and Physiotherapists will individually tailor your exercise sessions throughout the 12-week intervention. During the first six weeks of the intervention, you will be asked to attend three, 1 hour supervised exercise sessions per week. You will be provided with the option of performing these sessions at either the: School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia Campus, Brisbane, QLD, 4072 (free allocated parking directly outside the training facility)University of Queensland Healthy Living Clinic, 37 Archer Street, Toowong, QLD, 4066 (free parking available in the shopping centre directly across the road from the training facility) Translational Research Institute Clinical Research Facility, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102?During the remaining six weeks, you will be asked to perform two of the three supervised exercise sessions at the aforementioned exercise training facilities. However, you will be provided with the option to complete the third session either unsupervised at home, or supervised at one of the facilities. The supervised exercise visits will include balance and coordination exercises, followed by a circuit including short bouts of intense cardio exercise (e.g. using a treadmill, exercise bike, cardio rower or arm cycle), interspersed with longer recovery periods of low-to-moderate intensity cardio exercise. This will be paired with muscular strengthening and endurance, balance and flexibility exercises, ending with a cool down and stretching. Each session will last approximately one hour. If you chose to partake in the unsupervised home-based sessions from weeks 7-12 of the intervention, they will follow a similar format to that of the supervised exercise sessions. You will be provided with a copy of your exercise program and required to report whether you completed the exercises or not during each home-based session. This will be confirmed during your supervised sessions with your exercise specialist during weeks 7-8 of the program.Control Group If you are randomised to the control group, you will receive standard care from your treating physicians and will be encouraged to follow your normal exercise and lifestyle routine. You will not be provided with an exercise program. However, you will be provided with a copy of the American Cancer Society exercise guidelines. You will be asked to attend the testing sessions as described below. Testing SessionsAll participants will be required to attend testing sessions at four different time points during the study; baseline, 6 weeks, 12 weeks, and 6 months post-intervention. At each of these time points, you will be asked to attend 1-2 testing sessions lasting for approximately 1-2.5 hours each. All the testing measures will be performed during these 1-2 testing sessions. These sessions will assess any neurotoxicity development, and your cardiovascular health and aerobic fitness. You will also be provided with the option to complete the questionnaires at home prior to coming into your first testing session. A list of the tests to be conducted during each testing session, and at which time points they will be conducted, is provided below.At each of these times, you will also be asked to wear a physical activity monitor for 7 days after your last testing session. You will also be emailed a brief questionnaire (9 questions, 2 minutes to complete) each week for the first 12 weeks, asking whether you have experienced any symptoms of neurotoxicity. If you have noticed any symptoms of neurotoxicity, you will be asked to rate the intensity, distress and interference related to these symptoms (maximum 8 minutes to complete).Testing Session 1Questionnaires Height and Weight Neuropathy TestsCardiovascular Health TestsBlood TestShort Bike Test Testing Session 2 Cardiopulmonary Exercise TestThe following tests will be performed during Testing Session 2 at the baseline, 12 week and 6 month post-intervention time points. They will be performed during Testing Session 1 at the 6 week time point.Testing Session 1 or 2 Waist and Hip CircumferencesMuscle Strength Take home: ActiGraph for 7 days Provided on the next page is a timeline of when each of the above tests will be performed.AssessmentsBaselineWeek 6Week 126 month Post-intervention QuestionnairesxxxxHeightxWeight, Waist and Hip CircumferencesxxxxNeuropathy TestsxxxxCardiovascular Health TestsxxxxBlood TestxxxxMuscle Strength xxxxShort Bike Test xPhysical Activity MonitorxxxxCardiopulmonary Exercise TestxxxThese testing sessions will take place at the School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia, QLD, 4072 (free allocated parking directly outside the training facility). Pre-testing Requirements For 24 hours prior to each testing session, you will be asked not to consume any stimulants or depressants (e.g. coffee, tea, alcohol), tobacco or perform any vigorous exercise. You should take your normal daily medications. We will ask that you drink an adequate quantity of water (so that you do not feel dehydrated). Your consumption of food, drink, tobacco, medication and water, and exercise activities over the 24 hours prior to testing will be assessed via a survey. You will be required to complete and sign a survey, which will then be witnessed by the exercise specialist at the testing sessions.Testing Session 1The additional pre-test requirements for this testing session are to perform a 12-hour overnight fast, as your blood will be taken. In addition, if you take any medications for the treatment of high blood pressure (i.e. anti-hypertensives), you will be asked to not take them on the mornings of this testing session. However, you will be asked to bring these medications with you, so that you can take them immediately after the session has finished. You may take all your other medications as normal.QuestionnairesFive questionnaires will then be provided to you to complete at each time point either on a tablet device or, if preferred, via a paper copy. Completion of all the questionnaires will take approximately 22 minutes. The first questionnaire (FACT-Cog) will ask you questions relating to your cognitive function. Whereas the second questionnaire (FACT-G) will ask you questions relating to your physical, social/family, emotional and functional well-being. The third questionnaire (CIPNAT) will ask you questions relating to peripheral neuropathy symptoms. The fourth questionnaire (AQoL-8D) will assess quality of life, and the final questionnaire (Godin) will assess habitual physical activity. If you are randomised to the exercise intervention group, you will also be provided with one additional questionnaire at the baseline time point only, which looks at readiness for exercise participation. This questionnaire will take approximately 10 minutes to complete. If you feel uncomfortable answering any of these questions, please let the researchers know, as some of the questions may ask about sensitive information and you may skip these if you wish. You will then be asked to relax while laying on a (massage) bed in a dimly-lit, temperature controlled room. Further explanation of the tests to be conducted at baseline, 6 weeks, 12 weeks, and 6 months post-intervention are provided below.Neuropathy TestsA series of tests will be performed over your fingertips and toes to measure your responses to sensory stimuli, including touch and vibration. You will be asked to close your eyes and respond when you feel your finger/toe being touched with different sized plastic fibres. For testing of vibration, a tuning fork will be placed over your finger/toe and you will be asked to respond when you no longer feel any vibration. These tests will take approximately 10 minutes to complete. Any discomfort experienced during testing will be short lived and will not cause tissue damage.Cardiovascular Health TestsFlow-mediated Dilation with Skin Blood Flow During this test, we will be assessing the change in the width of the brachial artery in the right arm, as well as the change in blood flow in the capillaries underneath your skin. You will be asked to lay on a bed with your right arm placed straight out at your side, with your shoulder at 90 degrees. Your arm will be supported by 2 pieces of foam. A small pressure cuff will then be secured around your arm just below your elbow and a probe will be placed on your skin just above the elbow. During the test, the probe will remain on the skin and the cuff will remain inflated for 5 minutes. The test will last approximately 15-25 minutes. Meanwhile, two small probes (approximately 8 millimetres in dimeter each) will be placed on the top or bottom of your foot (near your big toe), and on your middle or index finger. These probes will gradually warm-up during a 30-minute period. A small cuff will also be attached to your left middle or index finger to measure blood pressure throughout the test. Carotid Intima-media Thickness and Distensibility This test will assess the structure and function of the carotid artery in your neck.You will be asked to remain on the bed in a relaxed state. Towels and/or pillows will be placed comfortably to support your head during the test. The probe will then be placed just above your collar bone on your neck and images of your carotid artery will be taken in three planes. The probe will then remain on your neck while a small pen-like device is put on the opposite side of the neck and images are taken again. The probe be removed upon completion. The taking of images in each of the three planes, and with the probe, should take approximately 60 seconds each. Pulse Wave Analysis This test will assess the function of your blood vessels. You will be asked to remain on the bed in a relaxed state. A blood pressure cuff will be attached to your right arm. During the test, the cuff will inflate and deflate. Each trial will last approximately 30 seconds and three trials will be performed. Pulse Wave Velocity This test will assess the stiffness of your blood vessels.You will be asked to remain on the bed in a relaxed state. A blood pressure cuff will be attached to your thigh. The clinician will then identify the location of the pulse in your neck and place a small mark (with a soft pen marker). The test will then begin when the thigh cuff inflates and the clinician will place a small blunt pen-like device on your neck. This pen will be held on your neck for the duration of the test and removed upon completion. Each trial will last approximately 30-60 seconds and three trials will be performed. Heart Rate Variability During this test, we will be assessing your resting heart rate variability.You will be asked to remain on the bed in a relaxed state. If necessary, a razor will be used to shave any excess chest hair. An alcohol wipe will be used to wipe the skin just above and below your sternum (breast bone) and on the left side of your ribs. Three small stickers (electrodes) will then be placed on your skin: (1) above the sternum, (2) below the sternum and (3) on a rib on your left side. Leads will then be attached to each of the three electrodes. You will then be asked to lay still for 5 minutes while the computer assesses your resting heart rate variability. Valsalva Manoeuvre This test will assess the response of your heart and blood pressure to a Valsalva manoeuvre. You will be asked to remain on the bed in a relaxed state. If necessary, a disposable razor will be used to shave any excess hair just above your wrists on your left and right arms and just above the ankle on your left leg. An alcohol wipe will be used to wipe the skin in these spots. Three small stickers (electrodes) will then be placed on your skin over your wrist and ankle. Leads will then be attached to each of the three electrodes. The small cuff on your left middle finger will remain on to measure blood pressure throughout the test. You will then be asked to blow into a mouthpiece for 15 seconds (creating a Valsalva Manoeuvre). You will be required to perform 3 trials in total, with rest allowed between each trial.Deep Breathing This test will assess the response of your heart and blood pressure to deep breathing. You will be asked to remain on the bed in a relaxed state. Your heart rate and blood pressure will continue to be monitored in the same way as in the above Valsalva test. You will also be required to wear a light-weight face mask to assess your breathing during this test. You will be asked to breath in for 5 seconds and then breath out for 5 seconds. This will be repeated six times in a row, leading to 6 breaths per minute. You be required to perform 3 trials in total, with rest allowed between each trial.Blood TestWhile you are seated comfortably, blood will be drawn by inserting a needle into a vein in your arm. At each visit, each sample will be approximately 33 mL; a total of about 198 mL will be drawn for the whole study. Your blood will be tested for markers relating to metabolic health and cancer cells. Your blood will be handled by professionals who have training in blood collection, and processing will only be performed by these professionals. Your samples will be stored in a secure location and will only be accessed by research staff. ?Short Bike Test This brief test will only be performed at baseline to familiarise you with the “Cardiopulmonary exercise test” to be held during testing session #2.During this test, you will be asked to maintain a pedalling frequency of 60 RPM on an exercise bike. The resistance on the bike will increase gradually throughout, with this test only lasting a few minutes and will remain at a light-to-moderate intensity. A face mask/snorkel will be attached to your face throughout to measure the amount of air you expire. Testing Session 2Cardiopulmonary Exercise Test (CPET) with Electrocardiogram (ECG)This test will be performed to determine your aerobic fitness/exercise capacity.A CPET is performed on an exercise bike with a face mask/snorkel to measure the amount and volume of air you expire. You will breathe normal room air throughout the test. The exercise test will last approximately 8-12 minutes, commencing at a light cycling load that will progress incrementally during the test. A pedalling frequency of 60-70 RPM should be maintain during the test. The test will be terminated once the participant reaches volitional fatigue. The test is completed with 5 minutes cycling at a low load. Blood pressure and ECG will be measured at regular intervals throughout the test and during recovery. An ECG shows the electrical activity of the heart.Testing Session 1 or 2Muscle Strength This test will assess the grip strength of both arms, which is correlated with overall body strength. You will be asked to grip a hand-held dynamometer and squeeze the handle as hard as possible for 3-8 seconds. This test will be performed three times on each arm.Take Home: Habitual Physical Activity - ActiGraph Your habitual physical activity will be assessed using the Actigraph GT3X+ accelerometer. You will be asked to wear the waist worn monitor for seven days immediately after your last testing session at each time point, to assess your time spent per week in light, moderate and vigorous physical activity. You will also be provided with a diary to record when the monitor is worn and any physical activity you perform while wearing the monitor.Risks of Participating in this StudyThere are minor risks associated with participating in this study.Intervention Group / Exercise Training (and Short Bike Test) A number of risks are associated with any exercise, including slightly elevated risks of a heart attack or stroke, in addition to muscle or joint injuries. To help reduce these risks, extensive screening of patient files has been performed and the first cardiopulmonary exercise test (CPET) you will undergo at baseline will include supervision from a medical doctor to ensure you are safe to exercise, as is consistent with the current exercise screening guidelines (American College of Sports Medicine, 2014). This is standard practice for any individual with a known medical condition in a research setting. If you do already have cardiovascular disease (e.g. history of heart attack, peripheral vascular disease), there is a risk that performing cardiopulmonary exercise during the exercise intervention could potentially exacerbate your condition. However, the supervised CPET will ensure that a medical doctor has assessed that you are safe to complete the exercise components of the study. You will also complete a warm up prior to and a cool down after exercise to reduce the risk of musculoskeletal injuries. Fatigue, muscle soreness, light-headedness, abnormal blood pressures, fainting, and nausea are also normal potential side effects of exercise training. You will be provided with guidance on how to manage these symptoms if they do arise, and exercise training sessions will be modified accordingly. Close monitoring by an exercise professional throughout the entire intervention will enable correct exercise technique to be performed to ensure participant confidence and safety. American College of Sports Medicine. (2014).?ACSM's guidelines for exercise testing and prescription.?(9th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.QuestionnairesSome questions will ask sensitive information. If you experience any distress with completing these questionnaires, you will be asked to please let the research staff know.Sensory TestingMild discomfort or pain may arise during sensory testing. Any pain or discomfort will be short-lived and not expected to persist after completion of the test. Stimuli will not cause any tissue damage.Cuff Inflation (Vascular Structure and Function Tests) Mild discomfort (e.g. pins and needles) may arise during the inflation of blood pressure cuffs on the finger, arms and leg during testing measures. The longest period of cuff inflation at a high pressure will be five minutes. Cuffs will not be inflated to such an extent or duration that will cause permanent damage to your finger, arms and leg. Blood Collection There are minor risks associated with a blood draw (i.e., bruising, infection, discomfort, light-headedness). However, this procedure is considered to be of minimal risk and will be performed by a trained phlebotomist. No syringes, lancets, needles or other devices capable of transmitting infection from one person to another shall be reused. All of these items will be destroyed after each use.Cardiopulmonary Exercise Test (CPET)There is a minor elevated risk of a cardiac event occurring during maximal exercise exertion. During CPETs at all time points an ECG will be recording your heart activity and blood pressures will be taken continuously throughout the test. A medical doctor will also be present at your baseline CPET to screen for any heart abnormalities. Exercise physiologists and individuals trained in cardiac investigations will be present for all CPETs at all time points to monitor the ECG trace and blood pressure responses to exercise. Illness or InjuryIf you become ill or injured as a result of participating in this study, please contact Natalie Vear (Study PH: 0473 550 978) and your general practitioner (GP). All appropriate measures will be taken to ensure a timely and appropriate course of treatment. Participant Confidentiality and Data ManagementParticipation in this study is entirely voluntary. You are free to withdraw from the study at any time. Withdrawal from the study will not affect your ongoing health care. Some personal information will be required for this study, for example your date of birth and health history. This information is needed for accurate data collection throughout the study. All data will be strictly confidential and only handled by the chief investigators for this study. All results from testing measures will be de-identified and stored under a unique identification (ID) number which will be assigned to you at commencement of the study. All data will be stored in accordance with the Princess Alexandra Hospital’s and University of Queensland’s relevant policies and procedures. What are the Benefits of Taking Part in this Study?Whether you are randomised to the intervention or control group, your involvement in this study will enable us to collect data which will help to further the knowledge of the effects of exercise on neurotoxicity development, as well as cardiovascular function, in the growing number of women affected by these conditions following chemotherapy. Additionally, if you are randomised to the exercise intervention group within this study, there are potential benefits, however these cannot be guaranteed. Greater physical activity involvement has been shown to be strongly associated with greater post-chemotherapy quality of life and function. You will also be provided with 12 weeks of closely-monitored and highly individualised exercise training by qualified exercise professionals free of charge. If you are randomised to the control group within the study, you will receive no such benefits but will still continue with your usual health care. Finally, no matter what group you are in, you will be provided free of charge with gold-standard measures of your aerobic fitness and vascular health. ReimbursementYou will not be paid to take part in this study. However, complimentary parking is available directly outside the School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus, Brisbane, Qld, 4072. Public transport options are also available. Access to ResultsOn completion of the study and upon request, you can be provided with group-level data. Once available and upon request, you are also provided with the option to be sent published data for the study.Who Can I Contact?If you have any questions or concerns regarding this project, please contact Natalie Vear (Study PH: 0473 550 978). Study InvestigatorsDr Tina SkinnerPhD, GCHigherEd, BAppSci(HMS – Ex Sci)(Hons)Senior Lecturer - Clinical Exercise PhysiologySchool of Human Movement and Nutrition SciencesLevel 5, Human Movement Studies Building (26B)Blair Drive, University of QueenslandSt Lucia, QLD, 4072Telephone: +61 7 3346 8810Email: t.skinner@uq.edu.auProfessor Sandie McCarthyPhD, MNsg, BNsg Dual Registered Nurse (Australia and New Zealand), Credentialed Cancer Nurse (Australia) Head of SchoolSchool of NursingUniversity of AucklandTelephone: +64 0 9923 3799Email:?alexandra.mccarthy@auckland.ac.nzNatalie Vear AEP ESSAM, BExSS(CEP)(Hons)PhD CandidateSchool of Human Movement and Nutrition SciencesThe University of QueenslandStudy Telephone: 0473 550 978Email: n.vear@uq.edu.auAdj Associate Professor Leanne Stone RN, RM, MN, CCNAdj Associate ProfessorSchool of NursingQueensland University of TechnologyDirector of NursingDivision of Cancer ServicesMetropolitan South Hospital and Health ServiceTelephone: +61 7 3176 5124Email: leanne.stone@health..auEthical ClearanceAll research in Australia involving humans is reviewed by an independent group of people, called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been reviewed by the HRECs at all participating sites in Queensland. This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies. Human Ethics Coordinator contact number: 07 336 53924An evidence-based intervention (“Fit for Treatment”) to prevent chemotherapy-induced neurotoxicity in breast cancer patients: An effectiveness-implementation hybrid studyResearch Study Title:An evidence-based intervention (“Fit for Treatment”) to prevent chemotherapy-induced neurotoxicity in breast cancer patients: An effectiveness-implementation hybrid studyStudy Principal Investigator:Dr Tina SkinnerPhD, GCHigherEd, BAppSci(HMS – Ex Sci)(Hons)Senior Lecturer – Clinical Exercise PhysiologyThe University of QueenslandCo-Investigators:Prof Sandie McCarthyDRN(Aus&NZ), CCN(Aus), PhD, MNsg, BNsg Head of School, School of NursingUniversity of AucklandNatalie VearBExSS(CEP)(Hons)PhD Candidate The University of Queensland Adj Associate Prof Leanne Stone RN, RM, MN, CCNAdj Associate Professor, School of Nursing, QUTDirector of Nursing, Division of Cancer ServicesMetropolitan South Hospital and Health ServiceConsent to Participate in “Fit for Treatment” StudyDeclaration by ParticipantI have read and understood the participant information sheet for this study and understand the procedures and risks involved. If required, someone has read the participant information sheet to me in language I can understand.I understand that I am able to withdraw from the study at any time without prejudice from The Princess Alexandra Hospital or The University of Queensland.I understand that I will receive no payment (monetary or otherwise) for being involved in this study. I am aware that all appropriate measures will be taken by the investigators to maintain participant confidentiality throughout this study. I have been given the opportunity to discuss the study contents with one of the investigators and any questions I may have had were answered satisfactorily. I understand that I will be given a signed copy of this document to keep. Name of Participant (please print) _____________________________________________Signature _____________________________ Date_________________________ Declaration by InvestigatorI have given a verbal explanation of the research project, its procedures and risks and I believe that the participant has understood that explanation. Name of Investigator (please print) _____________________________________________Signature _____________________________ Date__________________________ ................
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