Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform
研究概览
简要总结
The purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences in symptom management between intervention and usual care groups, and (3) identify potential outcomes of real-time symptom tracking and management.
With the assistance of the study coordinator, participants randomized to the intervention will create an account with Noona. Patients will be instructed to log symptoms as often as relevant using their own personal devices. Patients will also be prompted once per week for 24 weeks to log any recent symptoms. These participants will be sent a Symptom Questionnaire (SQ) via the Noona tool that summarizes their symptoms and distress one week prior to each oncology clinic visit. Symptoms designated as clinically severe either during regular symptom logging or via the SQ will trigger a prompt to contact the clinical team for immediate follow-up.
详细描述
New patients from three cancer care programs (thoracic oncology, gastrointestinal oncology, and palliative care) at two academic institutions (Stanford and UCSF) will be screened for demographic and disease stage data within the patient medical record. Eligible patients will be asked by their oncology team whether they would be interested in participating a study of symptom management in oncology care.
Patients who express interest and ability to participate will be interviewed to determine eligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Individuals (men and women) aged 18 years or older
- •Biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer
- •No limit on prior lines of therapy in the metastatic setting
- •ECOG performance status of 0-2
- •Estimated life expectancy of at least 6 months
- •Access to smartphone, tablet or computer with capability to utilize symptom tracking application
- •Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
- •Willing and able to comply with all study procedures
排除标准
- •Concurrent disease or condition that interferes with participation or safety
- •Non-english speaking, as the application is developed in the english language
- •Non-castrate resistant prostate cancer
- •Enrolled in other non-therapeutic or therapeutic clinical trials
研究组 & 干预措施
Noona web-based symptom tracking tool
In addition to usual care for their disease, patients interact with Noona system and system questioners to record their symptoms over a period of 6 months.
干预措施: Use of Noona web- based symptom tracking tool (Other)
Usual Care
Participants will receive the standard of care for their disease
结局指标
主要结局
Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform
时间窗: 6 months
Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) physical subscale score
时间窗: baseline, 6 months
Scores goes from (1-5). 5=Excellent and 1=Poor
Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) mental subscale score
时间窗: baseline, 6 months
Scores goes from (1-5). 5=Excellent and 1=Poor
次要结局
- Average number of diary encounters(6 months)
- Proportion of clinicians that report satisfactory use of the Noona system(6 months)
- Tabulated responses from Noona Patient Feedback questionnaire(6 months)
- Rate of SQ adherence(6 months)
- Change in overall Functional Assessment of Cancer Therapy-General (FACT-G) score(baseline, 6 months)
- Symptom experience(6 months)