ePainQ - a Web-based Pain Self-management System for Patients Undergoing Surgery for Breast Cancer: Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Successful completion of the ePainQ questionnaire
研究概览
简要总结
This is a feasibility study of a web-based pain self-management system aimed at providing support for acute postoperative pain and enhancing patient care. The ePainQ symptom questionnaire provides patients with immediate graded advice dependent on severity of issues reported. Information about self-managing these issues are provided via instructions in ePainQ with hyperlinks to more detailed advice on the ePainQ website. Patients log on daily postoperatively to complete the symptom questionnaire.
Women with invasive/non-invasive breast carcinoma due to be treated by surgery with curative intent will be approached to take part in this study. We will invite consecutive eligible patients, consenting as many willing patients as possible within a fixed 12 month recruitment period. There are 2 arms to the study: intervention -using ePainQ intervention & standard care and a cohort (control) arm, which will be standard care only.
Primary aim: To test the feasibility of a web-based pain self-management system for breast cancer patients undergoing surgery Secondary aims: 1. a) Examine preliminary effectiveness of the system (impact on outcome measures, pain etc.) b) Explore the potential associations between breast density, post-surgical scarring and pain and outcomes 2. To explore staff use and perceived usefulness of ePainQ in clinical consultations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged over 18 years of age at the time of diagnosis of cancer Primary operable (TNM categories: T1, T2, T3, N0, N1, M0; invasive breast cancer or non-invasive breast cancer (diagnosed on core biopsy or diagnostic incision biopsy) Ability to give informed consent Access to the internet (those without access to the internet may participate in the cohort arm) Ability to speak and write english
排除标准
- •Male Disease unsuitable for surgery e.g. inoperable, locally recurrent or metastatic disease Previously treated invasive breast cancer There will be a restriction to people who are able to speak/read English. This is due to lack of funding for translation of study documents Pregnant women Patients without capacity to consent or those with a major psychiatric disorder No internet access (those without access to the internet may participate in the cohort arm)
研究组 & 干预措施
Group 1 - Interventional Treatment
This group will be given the ePainQ questionnaire and an interview.
干预措施: ePainQ questionnaire (Other)
Group 2 - Usual care
This group will be receiving normal routine care without the study intervention
结局指标
主要结局
Successful completion of the ePainQ questionnaire
时间窗: 10 months from initial completion of questionnaire to feedback about experience
Feasibility of the ePainQ system is the primary outcome measure for the study. This will be examined in terms of: 1. Patient uptake rates 2. Patient engagement with/use of the system (e.g. log ins and completed questionnaires) 3. Patient retention rates 4. Representativeness of the participants (clinically and sociodemographic) 5. Patient feedback on perceived usability via qualitative interviews 6. System 'running burden' for the provider
次要结局
未报告次要终点