This study protocol outlines a pilot randomized controlled trial aiming to recruit 120 participants to evaluate a personalised primary prevention strategy for breast and prostate cancer.
RCT (n=120)
1:1 allocation
Yes
Does a personalised primary prevention strategy improve feasibility, acceptability, and uptake of preventive measures in women and men at high risk of breast and prostate cancer?
This study protocol outlines a pilot RCT to evaluate the feasibility and acceptability of a personalized primary prevention strategy for individuals at high risk of breast and prostate cancer.
Introduction Several primary prevention strategies, including chemoprevention, prophylactic surgery and lifestyle modifications, have been shown to reduce the risk of breast cancer (BC) and prostate cancer (Pca). However, the uptake of these preventive measures is considered suboptimal, limiting their impact on cancer prevention. A personalised primary prevention strategy has yet to be tested for cancer prevention. Therefore, we aim to determine the feasibility, acceptability and potential benefits and harms of this strategy in women and men at high risk of BC and Pca. Methods and analysis This is a two-arm, parallel-group mixed-methods pilot randomised controlled trial with a 1:1 allocation. The study aims to recruit 60 women and 60 men at high risk of BC and PCa in two specialised sites: the Breast Diseases Center and the Department of Urologic Oncology of the CHU de Québec-Université Laval, Canada. Assessments include intentions to uptake, actual uptake rates of primary preventive measures and decision regret. Feasibility and acceptability of the intervention and the study will be measured by quantifying the recruitment rate, appropriateness of randomisation process and satisfaction metrics. Data will be collected using mixed methods. Quantitative measures will be assessed at baseline and 6 months post randomisation. Quantitative analysis will include descriptive statistics for all variables of interest. Generalised linear mixed models with random intercepts will be used to assess the overall intervention effect. Semistructured interviews will be conducted at the end of follow-up, and a thematic analysis will be performed using NVivo to understand participants’ perspectives. Ethics and dissemination The protocol was approved by the Institutional Review Board of CHU de Québec-Université Laval (4 October 2022; 2023-6315). The findings of the study will be published in a peer-reviewed journal and disseminated at national and international conferences and through social media. Trial registration number The protocol for this study was registered with the International Clinical Trials Registry ( ISRCTN15749766 ) https://doi.org/10.1186/ISRCTN15749766 ).
Souli et al. (Sat,) conducted a rct in High risk of breast cancer and prostate cancer (n=120). Personalised primary prevention strategy vs. Control was evaluated on Feasibility, acceptability, intentions to uptake, actual uptake rates of primary preventive measures, and decision regret. This study protocol outlines a pilot randomized controlled trial aiming to recruit 120 participants to evaluate a personalised primary prevention strategy for breast and prostate cancer.