None listed
Conditions
Brief summary
Being overweight/obese and physical inactivity have been associated with increased cancer risk and all-cause mortality. Modifying lifestyle risk factors can decrease cancer recurrences and improve outcomes. Therefore, the aim of this study is to assess whether a structured lifestyle intervention delivered using an innovative method (virtual platform) in the early stage of breast cancer treatment has the potential to lead to earlier adoption or maintenance of a healthy lifestyle. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of early-stage breast cancer, and are being treated with either neo-adjuvant (i.e. before surgery) or adjuvant (i.e. after surgery) chemotherapy with curative intent for a minimum of 12 weeks. Study details All participants will take part in a 14-week virtual lifestyle intervention during chemotherapy treatment. This will involve a weekly 1-hour exercise session supervised by an exercise physiologist, and 1-hour dietary education session facilitated by a dietitian for 10-weeks, then fortnightly sessions for 4-weeks (total 24-sessions). The exercise prescription includes home-based exercise and involves resistance (e.g. exercise resistance band). Dietary sessions involve education about healthy eating, and strategies to improve psychosocial wellbeing. At the beginning and end of the 14-week intervention, participants will complete a number of online questionnaires to assess adherence to the intervention, satisfaction, safety, quality of life, and any lifestyle modifications. Participants will also undergo a number of tests of physical health remotely at the beginning and end of the intervention. These outcomes will be re-assessed at 6 months after commencement of the intervention, to determine whether any changes are sustained over this period. Participants will need to complete a daily diary including questions of physical activities and diet during 14-week intervention. It is hoped that this study may show that a virtually-delivered lifestyle intervention improves adoption and maintenance of a healthy lifestyle, which may lead to an improvement in quality of life and longer-term health outcomes for cancer survivors.
Interventions
Single arm intervention where participants will undergo one exercise and one diet education session per week for the first 10 weeks, followed by one exercise session and one diet education session every fortnight for the next 4 weeks so that a total of 24 supervised group exercise and group diet education can be delivered delivered virtually over a 14-week period throughout chemotherapy. For participants who have 12 weeks chemotherapy remaining can choose to have weekly exercise and diet educat
Single arm intervention where participants will undergo one exercise and one diet education session per week for the first 10 weeks, followed by one exercise session and one diet education session every fortnight for the next 4 weeks so that a total of 24 supervised group exercise and group diet education can be delivered delivered virtually over a 14-week period throughout chemotherapy. For participants who have 12 weeks chemotherapy remaining can choose to have weekly exercise and diet education sessions for 12 weeks continuously. Both dietary and exercise sessions will be delivered via Zoom, a virtual platform and each session will run for an hour. The exercise sessions will be run by an exercise physiologist (EP). Each group session will have no more than 15 participants per group. Individual exercise prescription will be provided at the baseline EP assessment session, and participants will be encouraged to follow the exercise prescriptions/instructions provided earlier during their intervention sessions. If unable to follow the exercise prescription, a new prescription will be given during the study intervention. The aim for these group exercise sessions is to encourage participants to exercise; reaching pre-specified level of intensity is not the main goal of exercise intervention. Participants will also be encouraged to do daily exercise in-between exercise sessions. EP will provide exercise/physical activities suggestions for in-between supervised group exercise sessions; based on individual's preference and capacity (e.g. daily walk or swimming twice per week, etc). Dietary sessions will be facilitated by a dietitian. Each session will focus on providing information related to healthy eating, and encouraging healthy eating patterns using motivational interview skills. There will be a mixture of group activities and discussion during the dietary sessions. Information/handouts used in this study are publicly available resources or resources from established organizations (e.g. Cancer council, World Cancer Research Fund, Health Department, etc) Strategies to monitor adherence will include daily diary (using survey function) asking participant's dietary intake and exercise/physical activities.
Sponsors
Faculty of Medicine and Health, University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults aged 18 years and over with early-stage breast cancer diagnosis who are to be treated with chemotherapy for curative intent (neo-adjuvant or adjuvant); - Have a minimum of 12 weeks of chemotherapy remaining to allow study participation; - Not on a special diet for medical reasons that contradicts high fibre, low fat dietary recommendations; - No known comorbidities limiting exercise (e.g. uncontrolled blood sugar level, blood pressure, etc). Medical clearance is needed if unable to pass exercise and fall risk screening questions; - Have valid email address and able to use it to access materials/web links for questionnaire and zoom links. If participants have no active email address but willing to create one for the study they will be eligible; - Have access to a device that enables access to a virtual platform (e.g, Zoom) to participate in exercise and dietary session; - Willing and able to comply with all study requirements, timing and/or nature of required assessments; - Fluent in English.
Exclusion criteria
- Fall risk without medical clearance - Cognitively impaired or unable to give informed consent; - Visual impairment affecting ability to follow instructions on screen to exercise safely; - Other advanced stage of malignancy; - Concurrent illness requiring high dose steroids (e.g. 25mg Prednisolone (or equivalent); - Presence of any psychological, familial, sociological or comorbidities potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence, drug abuse, eating disorder.
Outcome results
None listed