None listed
Conditions
Brief summary
This study aims to evaluate the effect of a 12-month eHealth exercise and diet program on the quality of life and wellbeing of women with metastatic breast cancer (MBC), compared to a current practice control Who is it for? This study is for women aged 18 years or older, who have been diagnosed with metastatic breast cancer in the previous 10 years, living in Australia and are well enough to partake in an exercise program. Study details Participants who choose to enrol in this study will be randomly allocated (by chance, similar to flipping a coin) to one of two treatment groups. Participants who are allocated to the first group will be given access to an eHealth-delivered exercise and diet program for 12 months. These participants will be able to attend up to 10 one-on-one remote video sessions with an Accredited Exercise Physiologist and up to 10 sessions with an Accredited Practising Dietitian. During each session the health professionals will work with participants to create a tailored exercise and/or eating plan to optimise participants' health and wellbeing. Participants who are allocated to the second group will continue to receive their current treatment/s from their specialists and will be encouraged to access existing services and resources (e.g., Breast Cancer Network Australia’s online tool to receive information and resources in relation to exercise and nutrition). The My Journey online tool is available to all Australian women diagnosed with breast cancer (https://www.bcna.org.au/understanding-breast-cancer/bcna-resources/my-journey/). The online tool also informs women of other existing community-based or online support options, including accessing support to allied health services (e.g., dietitians and exercise physiologists if they wish to) through a General Practitioner (GP)-coordinated Chronic Disease Management (CDM) Plan. Data Collection All participants will be asked to complete a physical assessment (via video), a DXA scan at a local imaging facility, an online questionnaire, and a food/drink recall at the time of enrolment, and then at 6 and 12 months after enrolment. At 3 and 9 months, participants will only complete a brief online questionnaire. It is hoped this research will determine whether a tailored telehealth exercise and diet program has a positive impact on the health and wellbeing of women with metastatic breast cancer. If this program is found to be effective it may be expanded across Australia for access by a larger number of metastatic cancer patients.
Interventions
Participants allocated to the Optimising Care intervention arm will receive a 12-month exercise and dietary intervention, delivered using an eHealth model (i.e., video-platform based on participant preference: Zoom, Teams) by an Accredited Exercise Physiologist (AEP) and Accredited Practicing Dietitian (APD). The intervention will be individually tailored (based on sites of metastatic disease, treatment-related side-effects, baseline assessment of outcomes, and pre-screening questions). Tailorin
Participants allocated to the Optimising Care intervention arm will receive a 12-month exercise and dietary intervention, delivered using an eHealth model (i.e., video-platform based on participant preference: Zoom, Teams) by an Accredited Exercise Physiologist (AEP) and Accredited Practicing Dietitian (APD). The intervention will be individually tailored (based on sites of metastatic disease, treatment-related side-effects, baseline assessment of outcomes, and pre-screening questions). Tailoring may include the number, frequency, and timing of sessions. Participants will have access to a maximum of 10 AEP sessions and 10 APD sessions over the 12-month intervention period. All sessions will be delivered one-on-one with the health professional, scheduled at a day and time convenient to the participant. Initial AEP and APD sessions will be approximately 1 hour each, with follow-up sessions approximately 30-45 mins in duration. Participants will be provided with a study workbook and logbook that outlines content delivered in sessions and the prescribed exercises, and helps participants keep track of the activities completed in between sessions. Participants will also be provided with resistance bands to assist with strength-based exercises at home. The exercise intervention will focus on increasing aerobic-based and resistance-based exercise (body weight, resistance bands or weights) activities, with a goal of achieving greater than or equal to 150 minutes of activity per week moderate intensity or higher and including 2 sessions of resistance exercises. The weekly exercise prescription, including the type, intensity and duration will be tailored to the individual. Common exercise to be prescribed will likely be walking and stationary cycling, as well as resistance exercises using resistance bands provided for home use. Exercise intensity will be recorded in the Logbook using the Rating of Perceived Exertion (RPE) Scale. The Dietitian will work with participants to make sure that they are eating well (e.g., sufficient protein intake) with a focus on improving your overall diet quality and helping to manage symptoms. Adherence to exercise and diet sessions (e.g., attendance, compliance to the prescribed exercises) will be recorded by the AEP in the case management file during eHealth sessions.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility will be based on the following inclusion criteria: 1. Women 2. Aged 18 years or older 3. Diagnosed with MBC in previous 10 years 4. Reside in Queensland, Australia 5. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 (self-reported by women, i.e., 0 indicates fully active, able to carry on all pre-disease performance without restriction; 1 indicates restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; or 2 indicates ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours)
Exclusion criteria
Few exclusion criteria will be applied to ensure broad generalisability of the sample, consistent with the pragmatic design. Women will be excluded only if they meet any of the following criteria: 1. Contraindications to participation in an exercise and dietary intervention (e.g., unstable angina, severe psychiatric condition) 2. Insufficient English to complete data collection and participate in the intervention
Outcome results
None listed