Evidence map›Paper›PMID 41615963›Full record

ArticlePloS one2026

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.

Susan Stinton, Dale Edwick, Chloe Maxwell-Smith, Natasha Bear, Lauren J Breen, Alejandro Dominguez Garcia, Elizabeth Dylke, Kate Edwards, Sally Lynch, Adam Lloyd and 5 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Susan StintonPhysiotherapy Department, Royal Perth Hospital, East Metropolitan Health Service, Perth, Western Australia, Australia.ORCID https://orcid.org/0000-0001-9645-5357
Dale EdwickCurtin School of Allied Health, Curtin University, Perth, Western Australia, Australia.
Chloe Maxwell-SmithSchool of Population Health, Curtin University, Perth, Western Australia, Australia.ORCID https://orcid.org/0000-0003-1694-2732
Natasha BearInstitute for Health Research, Notre Dame University, Perth, Western Australia, Australia.
Lauren J BreenSchool of Population Health, Curtin University, Perth, Western Australia, Australia.ORCID https://orcid.org/0000-0002-0463-0363
Alejandro Dominguez GarciaSchool of Population Health, Curtin University, Perth, Western Australia, Australia.
Elizabeth DylkeFaculty of Medicine and Health, The University of Sydney, New South Wales, Australia.
Kate EdwardsFaculty of Medicine and Health, The University of Sydney, New South Wales, Australia.
Sally LynchPhysiotherapy Department, Royal Perth Hospital, East Metropolitan Health Service, Perth, Western Australia, Australia.
Adam LloydCommunity & Virtual Care, East Metropolitan Health Service, Perth, Western Australia, Australia.
Barbara MullanSchool of Population Health, Curtin University, Perth, Western Australia, Australia.
Niamh MoloneyCurtin School of Allied Health, Curtin University, Perth, Western Australia, Australia.
Ru-Wen TehMedical Oncology Department, Royal Perth Hospital, Perth, Western Australia, Australia.
Carol WatsonPhysiotherapy Department, Royal Perth Hospital, East Metropolitan Health Service, Perth, Western Australia, Australia.
Kylie HillPhysiotherapy Department, Royal Perth Hospital, East Metropolitan Health Service, Perth, Western Australia, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAdults 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.

Indexed as

Breast NeoplasmsExercise TherapyAdultAustraliaExerciseFemaleHospitals, PublicHumansMiddle AgedQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodTertiary Care Centers

Identifiers

PMID41615963
PMCPMC12857944

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.