NCT04574063进行中（未招募）不适用
Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Goal achievement
研究概览
简要总结
A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. They will be told their estimated risk of developing breast cancer and will be randomised to one of three interventions:
- Breast cancer risk leaflet only
- lifestyle website
- lifestyle website plus group coaching.
Fifty per cent of women will also be randomised to have Single Nucleotide Polymorphisms (SNPs) performed, and these will be incorporated into their risk score.
The primary end point will be whether or not women achieve their lifestyle goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 30 and 60 years
- •Attending the symptomatic breast clinic at RMH Sutton or Chelsea OR the family history clinics at RMH Sutton or Chelsea, or has heard about the study through other means such as (but not limited to), friends who have been diagnosed with cancer, friends who are already taking part in the PIONEER study, social media, mainstream media, fliers through the doors of houses in the area of RMH.
- •Benign or B3 diagnosis if participant has attended clinic
- •Agree to receive their personalised breast cancer risk
- •Available to participate in a 1 year risk prevention programme
- •Able to attend the Royal Marsden for a blood test if randomised to this group
排除标准
- •Malignant Diagnosis
- •Does not want to find out personalised breast cancer risk
- •Not available to participate for the full year
- •NOTE: after risk assessment, women who have a breast cancer risk lower than that of population level will be excluded from participating in the behavioural change elements.
结局指标
主要结局
Goal achievement
时间窗: Women will be asked this 12 months after entering the study
Whether women have achieved their lifestyle goals. Proportion answering "yes" to a binary question: Did you achieve the goal you set? Compared between the three arms.
次要结局
- To assess the acceptability of randomisation to different arms of intervention(Measured when the final participant has completed 12 months in the study, estimated 15 months from start date)
- To assess the impact of SNP testing on changes in behavioural risk factors(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To assess the impact of the different interventions on changes in behavioural risk factors(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To identify whether there is an association between initial Cancer Worry Scale (Revised) score and change in behavioural risk factors(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To assess the acceptability of women to find out their personalised breast cancer risk and to commit to making a change in a modifiable risk factor(Measured when recruitment is complete, estimated at 3 months from start date)
- To assess the impact of knowledge of breast cancer risk on cancer anxiety scores(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To identify whether commitment to a study of this design is sustainable and affected by study group(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To assess the impact of the different interventions on uptake and adherence to chemoprevention at 1 year(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To consider the scalability of each element of the pilot study(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
研究者
研究点 (2)
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