Learning from a pilot RCT of breast cancer prevention by lifestyle modification


Year:

Session type:

R Law1, Katherine Krupa1, Jennifer Rusby1
1Royal Marsden NHS Foundation Trust

Abstract

Background

Breast cancer incidence is increasing and 23% is preventable: 8% caused by alcohol and 8% through being overweight or obese. Preventative strategies could have a major impact in combating this disease. The PIONEER study is a randomised pilot study, designed to identify the optimal support tool to empower women to reduce their breast cancer risk through lifestyle change.

Method

Randomisation is between standard written information, an interactive website providing information and support, and the third group can access the website together with facilitated peer support meetings (online). 240 women aged between 30 and 60 years will be recruited having been discharged from the diagnostic breast clinic with a benign or normal outcome. We present some important lessons for future prevention studies.

Results

84 participants have been recruited to date. Recruitment is now expected to take six times longer than estimated. Patient/participant involvement (PPI) for prevention studies is difficult. People who volunteer to co-design often do so because of a personal interest in the issue – survivors, clinicians or people with experience of a friend or relative with breast cancer. We believed the “teachable moment” of a clinic attendance with a breast symptom would be a driver for lifestyle change but patients have not been as keen to engage with a prevention project as anticipated through PPI. We have been recruiting since October 2020 when prevention of COVID has perhaps overshadowed other preventative efforts, yet 73% in a survey of 22 women in Summer 2020 said that reducing their risk of breast cancer was a priority and the “pandemic has not changed this”.

Recruits have self-selected into the study: An audit to inform study design showed that 34% of women attending the diagnostic clinic had an increased risk of developing breast cancer, yet 48% of women recruited are at increased risk. Our earlier audit showed 40% of our target population were at ‘less than population’ risk, yet only 22% of recruited women are.

Conclusion

Although consensus panels and PPI highlight prevention as a key gap in the research portfolio, recruitment is challenging, especially in a pandemic!

Impact statement

This study provides lessons for future prevention work.