Abstract

The clinical impact of direct-to-consumer genetic testing (DTC-GT) on health behavior change has remained controversial. The aim of this study is to clarify the short-term effects of DTC-GT on gynecological cancer screening uptake among middle-aged never-screened Japanese women in a randomized controlled trial (RCT). A total of 144 women aged 45–50 who had never undergone gynecological cancer screening were randomly selected to receive health education (control group), or health education and DTC-GT (intervention group), at a 1:1 ratio. We compared the gynecological screening uptake during the follow-up period. Furthermore, to estimate the impact of learning of an elevated genetic cancer risk in the intervention group, we conducted an analysis dichotomized by genetic risk category. A total of 139 women completed the one-year follow-up survey (69 in the control group and 70 in the intervention group). The follow-up period did not differ between control and intervention groups (the median follow-up period was 276 days and 279 days, respectively, p = 0.746). There were 7 (9.7%) women in the control group and 10 (13.9%) in the intervention group who attended breast cancer screening (p = 0.606), and 9 (12.5%) women from both groups attended cervical cancer screening (p = 1.000). Likewise, there were no significant differences in cancer screening uptake in the analysis stratified by risk category within the intervention group. In conclusion, there was no significant effect of DTC-GT on gynecological cancer screening uptake in this RCT setting. Increasing cancer screening attendance may require a combination of well-established intervention strategies and DTC-GT. Clinical Trial Registration: UMIN-CTR Identifier, UMIN000031709.

Highlights

  • The Organization for Economic Co-operation and Development (OECD) statistics show that breast and cervical cancer screening levels are as low as about 40% in Japan [3], despite the use of standard invitations and recall systems

  • Middle-aged women especially, are prone to have various barriers to participation in cancer screening. To motivate these individuals to undergo cancer screening, we focused on the receipt of personalized cancer risk predictions by direct-to-consumer genetic testing (DTC-GT)

  • There were no significant differences in cancer screening uptake in the analysis stratified by risk category within the intervention group

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Summary

Introduction

Breast and cervical cancer are the leading and tenth-most common cancers among. The incidence of both cancers among young and middle-aged women is higher than that of other malignancies [1,2]. The Organization for Economic Co-operation and Development (OECD) statistics show that breast and cervical cancer screening levels are as low as about 40% in Japan [3], despite the use of standard invitations and recall systems.

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