PhONEME - PartipatOn Ehealth MobilE. Effects of an Interactive Information and Communications Technology (ICT) Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- EORTC Prostate-specific module (QLQ-PR25) Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate the effects of an interactive ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate 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
- •Diagnosis of prostate cancer without metastases or spread to the lymph nodes,
- •will receive radiation therapy for at least five (5) weeks,
- •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
Intervention group
In combination with usual care according to the routines at the clinic, patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time.
干预措施: smartphone or tablet (Device)
Control group
Usual care according to the routines at the clinic.
结局指标
主要结局
EORTC Prostate-specific module (QLQ-PR25) Questionnaire
时间窗: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of symptom prevalence, characteristics and distress related to prostate cancer
Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)
时间窗: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of health literacy
Questionnaire Sense of Coherence Scale (KASAM)
时间窗: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of Sense of Coherence
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
时间窗: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of health related quality of life
Questionnaire Individualized Care Scale (ICS)
时间窗: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of individualized care as measured by the ICS
Questionnaire Scale for Functional Health Literacy (S-FHL - Swedish version)
时间窗: up to 3 months after completion of radiotherapy treatment
To evaluate self-reported data in terms of understanding and communicating health
次要结局
- Health care costs(up to 3 months after completion of radiotherapy treatment)
研究者
Ann Langius-Eklöf
PhD, RN, Professor
Karolinska Institutet