None listed
Conditions
Brief summary
This study is investigating a state-of-the-art exercise intervention for those undergoing chemotherapy for breast cancer in comparison to usual care. Who is it for? You may be eligible for this study if you are an adult with newly diagnosed, non-metastatic breast cancer, with planned treatment including neo-adjuvant or adjuvant chemotherapy and/or endocrine therapy. Study details Participants will be randomly allocated to receive either a tailored exercise program, or usual care pathways without individualized exercise prescription. The tailored program will involve supervision of exercise sessions and ongoing personal support. Participants will be asked to fill in questionnaires about their quality of life and absenteeism from work, and other health data including chemotherapy completion rates will also be collected. It is hoped that findings from this study will help evaluate the utility of a personalised exercise intervention during breast cancer treatment.
Interventions
The intervention will involve a state-of-the-art exercise program, with individual and periodized rehabilitation prescription, with adherence monitoring and regular one-on-one support to aid compliance. We refer to this as our “SMART” exercise intervention (Self-Determined, Monitored Adaptable Rehabilitation with Telehealth support). Individuals will be supported to build up or maintain a target exercise goal of 150 mins moderate intensity exercise per week (inclusive of 2 resistance sessions) as informed by guidelines from the American College of Sports Medicine for exercise and cancer. The intervention will run over a 16 week period. The target behaviour of the SMART program is for participants to work towards or maintain 150 minutes per week of moderate intensity exercise (or 75 minutes per week of vigorous intensity exercise) including two resistance training sessions per week. Moderate intensity exercise will be defined as exercise performed at 60 to 75% of their age predicted maximum heart rate. Vigorous intensity exercise will be defined exercise performed at > 75% of their age predicted maximum heart rate. Resistance training session will encompass the major muscle groups and will be defined as completion of 3 sets of 8-12 repetitions of strength-based or functional tasks (for example, sit to stand, bicep curls, squats). The goal will be to report an intensity that is perceived a 15 (‘hard’) on the 6 to 20 Rating of Perceived Exertion. Intensity will be progressed by increasing the resistance and/or to a more challenging movement pattern. It has been mentioned that side effects relating to breast cancer (BC) treatments are expected to lead to deterioration in physical capacity, as well as associated side effects including but not limited to nausea, dizziness, arthralgia or bone pain. Resultantly, it is reasonable to expect that there will be some days/weeks where many participants will not be able to meet the above target guidelines. In addition to the target program, lower intensity options will also be prescribed to account for the expected fluctuation in treatment related side effects. After initial recruitment, all study participants will complete an initial assessment to establish their baseline measures. The participants will be requested to complete the initial EORTC Quality of Life C30 questionnaire, as well as the breast cancer specific BR45 module. The trial physiotherapist will also assess participant muscle strength (grip strength, upper limb and lower limb muscle strength) and exercise tolerance (6-minute walking distance). Participant body composition will also be measured using the SOZO analyser. These outcomes are discussed in detail below. After the randomisation, the SMART intervention group participants will attend an hour-long initial assessment session with a physiotherapist. During this appointment, the physiotherapist will provide education regarding the target exercise goal. Patients individual exercise preferences and existing exercise habits will be discussed and a treatment plan and goals will be made to work towards achieving or maintaining the target exercise dosage. Online resources will be accessible by all participants in the SMART intervention group. These online resources will contain each individual with a personal login containing their target program, low intensity program, exercise logs, prompts to complete the program and to complete short questionnaires as required. The exercise programs will be available in written online form with short videos and/or photos specific to each individual. Flexibility in the program will be provided with exercises able to be completed either in participants own environment and/or during three weekly physiotherapy gym sessions at RPH. The participants in the SMART intervention group will also be given weekly one-on-one telehealth calls (up to an hour duration) from a physiotherapist to supervise exercise sessions, provide behaviour change strategies to encourage regular exercise habits through their BC treatment and to problem solve during weeks of low adherence to help them get 'back on track'. During these weekly sessions, feedback from symptom monitoring questionnaires will be discussed and exercise programs will be progressed or tapered accordingly.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults will be eligible to participate if they meet the following criteria: 1. Adult with newly diagnosed breast cancer 2. Planned treatment includes neo-adjuvant or adjuvant chemotherapy AND/OR endocrine therapy
Exclusion criteria
Adults will be not eligible to participate if they meet any of the following criteria: 1. Cognitive impairment or are unable to speak or read written English 2. Unable to access internet/phone app 3. Living in supported residential care 4. Any other co-morbidities where exercise is contra-indicated, at the discretion of the treating specialist