Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- volume and perimeter arm
研究概览
简要总结
Background: The cancer-related lymphedema (BCRL) is the abnormal accumulation of fluid in the lymphatic system and can develop immediately after surgery / radiotherapy of breast cancer, or may appear months later. In the literature there are numerous educational recommendations to avoid the appearance BCRL, but there is a lack of adherence to these recommendations. With the increase of mobile technologies among adults, the mobile devices can be an effective method to meet their education.
Objective: To determine the effectiveness of therapeutic adherence a brief educational intervention through a smartphone-based application in the prevention of lymphedema in women with mastectomies.
Method: 100 women survivors of breast cancer will be randomized to a group that will receive lymphedema prevention education and an app specific for better adhesion compared to the control group will receive education only. They will be monitored for 28 weeks by specific measures of lymphedema onset, volume and perimeter arm and hand strength lymphedema disability questionnaire and other measures of fatigue, quality of life and mood related to cancer.
Discussion: The lack of adherence to health education is the main cause of failure in maintaining these brief educational interventions, whether the program is beneficial, it could be successfully implemented in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
health education for lymphedema prevention
health education for lymphedema prevention
干预措施: health education for lymphedema prevention (Other)
application smartphone-based group
Health education plus Smartphone-based application sample will have a reminder to do education everyday where patients will have to select if they have done or they haven´t done compliance
干预措施: health education for lymphedema prevention (Other)
结局指标
主要结局
volume and perimeter arm
时间窗: baseline and 18 weeks
Water Displacement (volume) Is performed by the water displacement method, a volumeter to reference point 16 cm proximal to the olecranon, with a Tª of 21ºC. The upper limit is 65% of the distance from the olecranon to the acromion. Circumferential Measurement (Perimeter) The patient should be seated both arms on a table, shoulder in neutral rotation and in flexion of 45º, forearm in maximun supination, is measured at intervals of 5 cm along both arms, using elbow crease as starting point.
次要结局
- Quality of Life Breast CAncer QLQ-BR23 questionnaire(baseline; 18 and 28 weeks)
- Cancer related fatigue questionnaire(baseline; 18 and 28 weeks)
- volume and periemter arm(changes from 18 to 28 weeks)
- hand strength(baseline; 18 and 28 weeks)
研究者
Dr. Antonio I Cuesta-Vargas
PhD
University of Malaga