mHealth ALIBIRD: A Digital Health Care Model (Analysis of the Applicability of an m-Health Platform and Its Impact on the Follow-up of Patients With Cancer: Pilot Study in a Sample of Patients With Advanced Non-small Cell Carcinoma)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Usability and feasibility assesment
研究概览
简要总结
The aim of this pilot study was to evaluate the feasibility and acceptability of the ALIBIRD platform, a new mobile health (mHealth) application prototype design for personalized and remote support on the follow-up of cancer patients. The ALIBIRD platform is a mHealth intervention that tracks PROs, improving symptom control and allowing real-time feedback, and provides personalized recommendations and educational content, promoting empowerment and encourage healthy lifestyle behaviors in patients with thoracic neoplasms in active treatment.
详细描述
The investigators have developed an innovative mHealth platform that provides personalized recommendations based on Patient Reported Outcomes (PROs) records and the study of patient´s nutrigenomics and gut microbiome. The usability of the ALIBIRD mHealth platform prototype is being tested in a 28-week pilot study carried out at Infanta Sofía Hospital. A small group of stage IV thoracic neoplasms patients (n=20) were asked to participate. All the participants gave informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with thoracic neoplasms, histologically or cytologically confirmed.
- •< 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patients receiving cancer treatment: chemotherapy, chemotherapy-immunotherapy, immunotherapy or biological therapy.
- •Patients with internet access and intermediate level in the use of technology (Smartphone, mobile applications, wearable)
- •Signed informed consent.
排除标准
- •Patients with symptomatic brain metastases.
- •Patients with neurological impairment, dementia or psychiatric disorders.
- •Patients unable to follow the protocol due to psychological, social or geographic reasons.
结局指标
主要结局
Usability and feasibility assesment
时间窗: week 1 to 28
Changes in Satisfaction System Usability Scale (SUS)
次要结局
- Changes in physical activity (International Physical Activity Questionnaire,PAQ)(Week 1 to 28)
- Changes is Hospital Anxiety and Depression Questionnaire (HADs) from baseline(Week 1 to 28)
- Changes in Mediterranean Diet Serving Score (MDSS)(Week 1 to 28)
- Changes in Quality of life ( The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13, EORTC QLQ-LC-13)(Week 1 to 28)
- Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline(Week 1 to 28)
- Changes is medication adherence (MMAS-8 questionnaire)(Week 1 to 28)
- Changes in Quality of life ( European Quality of Life-5 Dimensions 5 Levels questionnaire,EQ-5D-5L) from baseline(Week 1 to 28)
- Changes in sleep (Pittsburg questionnaire)(Week 1 to 28)
- Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire)(week 1 to 28)
- Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ)(Week 1 to 28)