Skip to content

Optimising care: a program supporting women with metastatic breast cancer to be active and eat well

Optimising care: a pilot study evaluating the feasibility, safety and preliminary efficacy of an exercise and dietary intervention for women with metastatic breast cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000027213
Enrollment
36
Registered
2018-01-12
Start date
2018-09-25
Completion date
2019-10-29
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 p

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

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026