ABSTRACT

Adults undergoing treatment for breast cancer (BC) are advised to participate in regular exercise. However, many struggle to exercise consistently due to the side effects of systemic treatments including nausea, fatigue, and pain. In adults with newly diagnosed BC, this trial will evaluate the effectiveness of a new exercise intervention, compared with usual care, on outcomes including health-related quality of life (HRQoL).

Materials
This randomised controlled trial is underway at an Australian tertiary hospital. The protocol was prospectively registered (Australian New Zealand Clinical Trials RegistryACTRN12623001168640p). Consenting adults with BC diagnosed within the prior six months, with planned chemotherapy and/or endocrine treatment will be randomised to an intervention or control group. Both groups receive usual physiotherapy and medical care. Those allocated to the intervention group are offered participation in the ‘SMART’ intervention (Self-determined, Monitored, Adaptable, Rehabilitation with Telehealth support). This involves 16-weeks of tailored, one-on-one physiotherapy-led exercise sessions including behaviour change techniques and the weekly goal of completing 150 minutes of aerobic exercise and two resistance training sessions. The primary outcome is HRQoL and secondary outcomes include physical assessments (muscle strength, exercise tolerance, body composition), healthcare utilisation, workplace absenteeism, mood, psychological determinants of behaviour change, chemotherapy completion rates and endocrine therapy completion. All outcomes are measured prior to randomisation and 16 weeks following randomisation. Additional assessments of all outcomes (excluding the physical assessment) occur at 8 weeks and 52 weeks following randomisation. Ongoing recruitment for two years from June 2024 is expected to achieve a sample size of 260. No results have been analysed.

Discussion
If the SMART intervention produces favourable change, this will support its adoption in clinical practice. A greater understanding of factors including BC stage, treatment type or variables relating to the exercise program, that influence the magnitude of exercise-induced change on HRQoL will inform future exercise programs.

Stinton, S., D. Edwick, C. Maxwell-Smith, N. Bear, L. J. Breen, A. D. Garcia, E. Dylke, K. Edwards, S. Lynch, A. Lloyd, and 5 more contributors. 2026. Evaluating the effect of the SMART intervention in people with recently diagnosed breast cancer who are being treated at a public tertiary hospital in Australia: protocol and statistical analysis plan for a single-blinded, single centre randomised controlled trial.Plos One 21 (1 January)

ABSTRACT
Health behaviours, such as physical activity, should be encouraged for primary and secondary prevention of non-communicable diseases. Community-based interventions delivered in non-clinical settings may serve to promote such health behaviours while capitalising on existing infrastructures. Such interventions can cater to the needs and preferences of specific community groups and hence have the potential to be accessible, appropriate, and appealing when designed and implemented appropriately. To design sustainable community-based interventions, it is important to outline the parameters of the intervention setting and establish and maintain stakeholder engagement. However, inequalities may exist whereby some effective interventions either do not reach or are less effective for population sub-groups. Thus, interventions may require adapting, tailoring, or targeting to reach across the social spectrum. The effectiveness and sustainability of community-based health behaviour change interventions require alignment between the target population, key stakeholders, and public health policy.


Mullan, B. A., C. Liddelow, H. Breare, and C. Maxwell-Smith. 2025. Health behaviour change interventions.In Routledge International Handbook of Health Psychology Global and Contemporary Issues, 495-507