PhONEME - ParticipatOn Ehealth MobilE. Effects of an Interactive ICT-platform for Assessment and Management of Symptoms in Patients Treated for Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
研究概览
简要总结
The purpose of this study is to evaluate the effects of an interactive Information and Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of breast cancer
- •Patients who will receive neoadjuvant chemotherapy
- •Literacy in the Swedish language
排除标准
- •Patients who need an interpreter at the doctor's visit
- •Patients who have a known severe cognitive impairment
研究组 & 干预措施
Control group
Standard care according to the clinic's routines.
Intervention group
Use of an application for a smartphone or tablet for daily reporting symptoms and access to self-care advice and health care professionals in real time in combination with standard care according to the clinic´s routines
干预措施: Smartphone or tablet (Device)
结局指标
主要结局
Questionnaire Scale for Functional Health Literacy (S-FHL-Swedish version)
时间窗: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of understanding health
Questionnaire Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
时间窗: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of communicating health
Questionnaire Individualized Care Scale (ICS)
时间窗: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of individualized care
Questionnaire Sense of Coherence Scale (KASAM)
时间窗: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of Sense of Coherence
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
时间窗: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of health related quality of life
Questionnaire Memorial Symptom Assessment Scale (MSAS)
时间窗: Up to 3 months after completion of neoadjuvant chemotherapy treatment
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress
次要结局
- Health care costs(Up to 3 months after completion of neoadjuvant chemotherapy treatment)
研究者
Ann Langius-Eklöf
RN, PhD, Professor
Karolinska Institutet