Optimising Care: Supporting women with metastatic breast cancer to optimise their quality of life via exercise and diet

Not Applicable

Recruiting

• Conditions: metastatic breast cancer; Cancer - Breast

• Registration Number: ACTRN12622001494729
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported physical function as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; version 3.0) – physical functioning scale.[ Self-reported physical function will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention; primary time point).];Whole body lean mass as measured by Dual-energy X-ray Absorptiometry (DXA) body scan.[ Whole body lean mass will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention; primary time point).]