PREHapp Study Protocol: Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery: a Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Usability
研究概览
简要总结
Pilot study to evaluate the effect of prehabilitation programme through a mobile application PREHapp in colon cancer surgery. The objectives of this pilot study were to evaluate the usability of the PREHapp for people undergoing colon cancer surgery, estimate the effect of the app on functional recovery after surgery and to evaluate complications during the postoperative period after 4 weeks of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 18 years.
- •Diagnosis of resectable colon cancer with elective surgery.
- •Participants have at least 2 weeks to their operation date.
- •Agree to collaborate in the study and sign the informed consent
排除标准
- •Diagnosis of unresectable colon cancer.
- •Inability to follow the prehabilitation programme.
- •Participants be able to understand written and spoken Spanish.
- •Subjects with previous nutritional supplements.
- •Pre-anesthetic evaluation with results, according to the classification of the American Society of Anesthesiologists (ASA) IV or V.
结局指标
主要结局
Usability
时间窗: 2 year
Evaluate the usability of PREHapp with the System Usability Scale (SUS). The SUS is a reliable and valid 10-statement usability scale suitable to assess a wide range of eHealth technologies. The total SUS score ranges from 0 to 100, and higher scores reflect higher usability. An SUS score of at least 62.7 was considered acceptable, and 68 or above was regarded as above average in terms of usability quality
次要结局
- Functional recovery(2 year)
- Complications(2 year)
研究者
Luis Sánchez Guillen
MD, Staff Colorectal Surgeon
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana