Evaluación Del Impacto de Una intervención Multidimensional, Con Herramientas TIC, en la Calidad de Vida de Las Pacientes Supervivientes al cáncer de Mama
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Quality of Life of cancer patients
研究概览
简要总结
mACMA is a pilot study that is developed for breast cancer survivors of the Hospital Clinic of Barcelona. The objective of this study is to evaluate the progress in quality of life through the introduction of a mobile phone App that allows for symptom tracking, physical activity tracking and a calendar of patient-oriented events organized by patient organizations. This study is a two-arm randomized clinical trial.
This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 875351.
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
- 是
入选标准
- •Previous diagnostic of breast cancer
- •Free of disease at the time of randomization
- •Signed consent form
- •Possession of a smartphone and ability to use smartphone applications
- •Patients belonging to the ACMA group o being treated at Hospital Clínic
- •Without diagnosis of neurodegenerative disorders that prevent participation in the study
排除标准
- •Acute process of cancer at the moment of recruitment
- •Active treatment for cancer (chemotherapy, radiotherapy)
- •Comorbidities such as heart failure NYHA class 4, COPD,...
- •Inability to give informed consent
研究组 & 干预措施
mHealth intervention
Installation of the mHealth application Xemio in the participant's smartphones. Voluntary use of the application for 12 months. Outcome measures collected every 3 months.
干预措施: Xemio mobile application (Other)
Control
No application installed. Outcome measures collected every 3 months.
结局指标
主要结局
Change in Quality of Life of cancer patients
时间窗: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Measured as 0-100.
Change in Quality of Life specific to breast cancer patients
时间窗: Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study)
European Organisation for Research and Treatment of Cancer Breast 23 (EORTC BR-23). Measured as 0-100.
次要结局
- Change in Social Determinants of Health(Baseline and t= 12 months)
- Steps(Continuous (12 months))
- Change in Anxiety and Depression(Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study))
- Symptoms reported with the Xemio mobile application(Continuous (12 months))
- Change in Loneliness(Baseline, t=3 months, t= 6 months, t= 9 months, t= 12 months (completion of the study))
- Change in Weight(Baseline and t= 12 months)
- Change in Body Mass Index (BMI)(Baseline and t= 12 months)
- Change in Fat mass percentage(Baseline and t= 12 months)
- Change in muscle mass percentage(Baseline and t= 12 months)
- Use of the Xemio mobile application(Continuous (12 months))
研究者
Imma Grau
Principal Investigator
Hospital Clinic of Barcelona