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

## TL;DR

This paper summarizes lessons from a decade of trials on a lifestyle intervention for women after cancer treatment, highlighting the limitations of randomized controlled trials and suggesting alternative study designs.

## Contribution

The paper proposes that mixed-method, non-RCT approaches are more suitable for evaluating health behavior interventions in cancer survivors.

## Key findings

- RCTs have limitations in assessing behavioral interventions for cancer survivors.
- Consumer advocates and participants influenced study design changes.
- Non-randomized pre-post or waitlist control designs are acceptable alternatives.

## 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.

•Lessons learned from a decade of the Women's Wellness after Cancer Program trials.•Study design and outcomes interpreted by consumers (advocates and participants).•Quantitative RCT methodology not ideal for assessing health behaviour interventions.•A mixed method, non-RCT approach to evaluate intervention efficacy is suggested.•Otherwise, non-randomised pre-post, A/B or waitlist control test designs acceptable.

Lessons learned from a decade of the Women's Wellness after Cancer Program trials.

Study design and outcomes interpreted by consumers (advocates and participants).

Quantitative RCT methodology not ideal for assessing health behaviour interventions.

A mixed method, non-RCT approach to evaluate intervention efficacy is suggested.

Otherwise, non-randomised pre-post, A/B or waitlist control test designs acceptable.