Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Qualitative Stage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number and content of themes and subthemes describing PCa patients' perceptions of the risk of breast-related side effects, including gynaecomastia, from high-risk BCR PCa treatment.
研究概览
简要总结
This study aims to explore the perceptions of men with prostate cancer (PCa) and high-risk biochemical recurrence (BCR) regarding the risk of breast-related side effects, including gynaecomastia, from treatment.
详细描述
This study will inform a set of 'attributes' and their levels that can be used in a later discrete choice experiment (DCE), for which separate ethical approval will be sought, to assess the trade-offs patients are willing to make between breast-related side effects, other quality of life (QOL) impacts and cancer control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with high-risk BCR PCa but no ADT+/-ARPI experience.
- •Men with ADT+/-ARPI experience who have experienced breast-related side effects from this treatment.
排除标准
- •Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.
研究组 & 干预措施
A qualitative approach with semi-structured interviews.
Through purposive sampling, we plan to conduct interviews with men from two groups: those with high-risk BCR PCa but no ADT+/-ARPI experience, and men with ADT+/-ARPI experience who have experienced breast-related side effects from this treatment. To inform an understanding of how perception of breast-related symptoms might inform treatment preferences, it is important to understand perspectives regarding the hypothetical risk of side-effects as well as those based on actual experience.
干预措施: Semi-structured Interview (Other)
结局指标
主要结局
Number and content of themes and subthemes describing PCa patients' perceptions of the risk of breast-related side effects, including gynaecomastia, from high-risk BCR PCa treatment.
时间窗: 12 months
The outcome will be the set of themes and subthemes identified through qualitative analysis of semi-structured interviews. Interviews will be conducted with three groups: (1) men with high-risk BCR prostate cancer; (2) men with ADT ± ARPI experience; and (3) men who have experienced breast-related side effects from prostate cancer treatment.
次要结局
- Number and content of discrete choice experiment (DCE) attributes and their levels, developed to assess the trade-offs patients are willing to make between breast-related side effects, other QoL impacts, and cancer control.(12 months)
研究者
Anthony Joshua, FRACP
Medical Oncologist
St Vincent's Hospital, Sydney