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

{"title":"Ten years of Women's Wellness research: Key lessons from conducting randomised controlled trials of a whole-of-lifestyle behavioural intervention","authors":"Sarah M. Balaam , Alexandra L. McCarthy , Natalie K. Vear , Mackenzie J. Petie , Debra J. Anderson , Janine P. Porter-Steele","doi":"10.1016/j.conctc.2025.101441","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div><div>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.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101441"},"PeriodicalIF":1.4000,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865425000158","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

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.