Evaluating a Digital Tool for Supporting Breast Cancer Patients: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Comparison of the change in patient activation (validated questionnaire: Patient Activation Measure (PAM-13) Survey)
研究概览
简要总结
This is a prospective randomised controlled trial that aims to understand the impact of the OWise breast cancer digital tool in newly diagnosed breast cancer patients. Half the patients will receive the digital tool and half the patients will receive standard information. The study will look at the impact of the digital tool on patient activation, health related quality of life (HRQoL), health status, psychological distress, NHS resource utilisation and health care costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •adult (age 18 years or over)
- •newly diagnosed
- •early breast cancer
- •first primary cancer diagnosis
- •under treatment at one of the participating sites.
排除标准
- •have started anti-cancer treatment
- •private patients
- •unable to read or write in English
- •significant cognitive impairment
- •poor mental health
- •do not have access to the internet
- •confirmed metastatic disease
结局指标
主要结局
Comparison of the change in patient activation (validated questionnaire: Patient Activation Measure (PAM-13) Survey)
时间窗: 3 months after diagnosis (primary objective); 6 months and 1 year (secondary objective)
The Patient Activation Measure (PAM-13) is a 13-item questionnaire measuring confidence in self management and knowledge of health condition. Each item has four possible responses from (1) strongly disagree to (4) strongly agree, with an additional 'not applicable' option. The measure views activation as a developmental process of four different levels, with the lowest scores corresponding to 'not believing activation important' and the highest scores corresponding to 'taking action.' The total score is calculated by dividing the raw score by the number of items answered (excluding items where 'not applicable' was selected) and multiplying by 13. This score is transformed using calibration tables to a scale with a theoretical range of 1-100, with a higher PAM score indicating higher patient activation.
次要结局
- Comparison of the change in psychological distress (validated questionnaire: HADS)(3 months, 6 months and 1 year after diagnosis)
- Resource Utilisation(1 year)
- Comparison of the change in health status (validated questionnaire: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Survey)(3 months, 6 months and 1 year after diagnosis)
- Comparison of the change in health related quality of life (validated questionnaire: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core30 (EORTC-QLQ-C30 version 3) Survey)(3 months, 6 months and 1 year after diagnosis)
- Health care costs(1 year)