None listed
Conditions
Brief summary
The aim of this study is to assess the feasibility and safety of an individually-tailored exercise and dietary program for women with metastatic breast cancer (MBC) and provide preliminary evidence on changes in patient-relevant outcomes such as quality of life. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or over and have a diagnosis of metastatic breast cancer in the previous 5 years, or progression of metastatic disease over the last 2 years. Study details All women will receive a 16-week exercise and dietary program, individually-tailored based on their baseline assessment, tumour burden and treatment. The program will focus on increasing exercise (aerobic- and resistance-based), improving diet quality and managing nutritional symptoms (e.g., nausea/vomiting, constipation/diarrhoea), to improve (or attenuate declines in) quality of life, lean body mass and physical function. Data will be collected at baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention) and 10-months (T3/six-months post-intervention). We hypothesise that a 16-week exercise and dietary program will be feasible and safe for women with MBC and will improve (or reduce declines in) patient-relevant outcomes.
Interventions
All participants will receive a 16-week exercise and dietary program, tailored to their individual needs. The exercise program will focus on increasing aerobic-based and resistance-based exercise. Women will have eight supervised exercise sessions with an accredited exercise physiologist (AEP) based at their local gymnasium, their home or another location convenient to the participant. The target dose of exercise will be for participants to complete 150 minutes of moderate intensity activity per week, including two sessions of resistance exercises. The data collected as part of the baseline assessment will be used to inform and guide the initial exercise prescription. The exercises will be progressed and adapted as appropriate, with a tapering of frequency of contacts with the AEP over the course of the program. The dietary program will focus on ensuring adequate consumption of protein, increasing diet quality and managing nutritional impact symptoms (e.g. nausea/vomiting, constipation/diarrhoea), which will be common in women undergoing chemotherapy. Women will have an initial one-on-one face-to-face session with an accredited practising dietitian (APD), followed by seven telephone sessions. The dietitian will also discuss participants' goals and preferences in relation to dietary intake and will use this to tailor the content and focus of sessions. Women will complete three study assessments over a 10-month period: baseline (T1/pre-intervention), 16-weeks (T2/end-of-intervention) and 10-months (T3/6-months post-intervention).
Sponsors
Study design
Eligibility
Inclusion criteria
- Diagnosis of metastatic breast cancer in the previous 5 years, or progression of metastatic disease over the last 2 years - Estimated prognosis of 12 months or more as deemed by the treating oncologist - ECOG performance status 0 – 2 (i.e. ‘fully active, able to carry on all pre-disease performance’ through to ‘ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours’) - Deemed otherwise suitable for participation in an exercise and dietary intervention by the treating oncologist (e.g. no significant comorbidities such as unstable angina or significant psychiatric conditions) - Reside within the greater Brisbane area and able to travel for assessments - Willing and able to provide written informed consent
Exclusion criteria
- Pregnant - Insufficient English to complete assessments and participate in the intervention - Unable to travel to Brisbane to complete study assessments