Ten years of Women's Wellness research: Key lessons from conducting randomised controlled trials of a whole-of-lifestyle behavioural intervention

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-03 DOI:10.1016/j.conctc.2025.101441

Sarah M. Balaam , Alexandra L. McCarthy , Natalie K. Vear , Mackenzie J. Petie , Debra J. Anderson , Janine P. Porter-Steele

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Abstract

Many women are diagnosed with breast cancer and while the survival of this cohort has improved, their likelihood of developing treatment-related chronic conditions is considerable. Over the last 10 years, our research group has developed and refined a whole-of-lifestyle intervention, the Women's Wellness after Cancer Program (WWACP), for women who have finished treatment for primarily breast and gynaecological cancers. Culturally-specific iterations of this program were recently completed with younger breast cancer survivors (aged <50 years) living in Australia, New Zealand/Aotearoa and Hong Kong.

Over the last decade, various approaches have been used to trial the WWACP, mostly randomised controlled trials. While this methodology is considered the gold standard to determine efficacy in health and medical research, its limitations in our interventional research are apparent. In this opinion article, we discuss these limitations as well as alternative options for the appropriate testing of behavioural studies in women treated for cancer. We also discuss how the contribution of informed consumer advocates and participant consumers has influenced changes to our study designs.

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十年的女性健康研究：全生活方式行为干预随机对照试验的重要经验

许多妇女被诊断患有乳腺癌，虽然这一队列的生存率有所提高，但她们患上治疗相关慢性疾病的可能性相当大。在过去的10年里，我们的研究小组已经开发并完善了一种全面的生活方式干预，即癌症后妇女健康计划（WWACP），主要针对已完成乳腺癌和妇科癌症治疗的妇女。该项目最近在澳大利亚、新西兰/新西兰和香港的年轻乳腺癌幸存者（50岁）中完成了文化特定的迭代。在过去的十年中，人们使用了各种方法来试验WWACP，其中大多数是随机对照试验。虽然这种方法被认为是确定健康和医学研究疗效的黄金标准，但它在我们的介入性研究中的局限性是显而易见的。在这篇观点文章中，我们讨论了这些局限性，以及在接受癌症治疗的妇女行为研究中适当测试的替代选择。我们还讨论了知情消费者倡导者和参与消费者的贡献如何影响我们研究设计的变化。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.