The UNTIRE App Trial: The Feasibility of Using the Untire App for the Colorectal Cancer Patient to Manage Their Cancer Related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
This research is being done to find out if using a smartphone app as digital treatment to reduce Cancer Related Fatigue is feasible and easy to use.
This research study is evaluating a smartphone application named the "Untire" app. The Untire app was designed as a digital treatment plan for people experiencing Cancer Related Fatigue (CRF).
详细描述
This is a single arm, pilot study evaluating the feasibility, acceptability, and effectiveness of a self-managed digital therapeutic application, the Untire App, for the treatment of cancer-related fatigue in the Colorectal (CRC) cancer patient community.
The Untire app was developed by Psychology Oncologists and combines proven treatments for Cancer Related Fatigue like cognitive behavioral therapy, mindfulness exercises, physical activities, education, and positive tips. The Untire app helps a patient recognize and learn about daily behaviors, fatigue levels, and energy levels. The Untire app has been tested on all different cancer types globally and has been proven to decrease fatigue and improve overall quality of life but this is the first-time investigators are examining the strengths and weaknesses of using the Untire app as a digital treatment plan for Cancer Related Fatigue.
The research study procedures include screening for eligibility and study interventions including smartphone app use and evaluations with questionnaires and follow up visits.
Participants will be in this research study for up to 12 months.
It is expected that about 60 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •>/= 18 years of age
- •Owns a smart phone or Ipad
- •Diagnosis of Metastatic Colorectal Cancer, adenocarcinoma
- •Actively undergoing treatment for Metastatic disease
- •Speak and read English at a 6th grade level or higher
- •A score of 1 or greater on the PRO CTACE DFCI fatigue (questions 53a or 53b)
排除标准
- •Patients in Surveillance
- •Patients receiving end of life care
- •Patients taking dexamethasone other than for the control of nausea
- •Patients taking methylphenidate (Ritalin) for the treatment of CRF
结局指标
主要结局
Enrollment Rate
时间窗: 3 months
Primary outcome is feasibility. Feasibility will be described as the number and percentage of enrolled patients that used the app more than once.
次要结局
- CSQ-I Score(3 months)
研究者
Nina Grenon, NP
Principal Investigator
Dana-Farber Cancer Institute