Evaluation of a Mobile App to Promote Social Support for Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- Change in Short-Form Health Survey (SF-12)
研究概览
简要总结
Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.
详细描述
The app is designed to be used by the patient and members of their support network. It provides wide-ranging functionality, including: reminders for appointments and tasks, the ability to track health measures (fitness, emotion, pain, sleep), archive health related documents, maintain notes and recordings from visits, social networking functions to connect with family and friends to coordinate support activities and share news, and educational resources. We will randomize 230 patients initiating chemotherapy cancer treatment and up to one caregiver to the App group (asked to use the app once or more per week) or the Usual Care group, and evaluate the 3-month efficacy of app use on key outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •At least 18 years of age
- •Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy
- •Have a valid email address
- •Have a smart mobile device (Android or iOS) with a data plan
- •Willing to download and use the study app
排除标准
- •Unable to communicate in English.
结局指标
主要结局
Change in Short-Form Health Survey (SF-12)
时间窗: Baseline, Three months
a. Investigators will measure differences in quality of life between the two study arms with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
时间窗: Baseline, Three months
a. Investigators will measure the relative changes in functional status of cancer patients using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. FACT-G is a 27-item questionnaire asking participants to report the four primary QoL domains, including physical, social/family, emotional and functional well-being on a 5-point Likert scale where 0 = Not at all to 4 = Very much with higher scores representing better general QoL.
次要结局
- Caregiver's Burden(Baseline, Three months)
- Caregiver's Disruptiveness(Baseline, Three months)