Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification (INSIGHT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to first acute care visit
研究概览
简要总结
This clinical trial compares intensive symptom evaluation with supportive care to standard symptom management in patients with head and neck cancer that has not spread to other places in the body (non-metastatic). Standard symptom management involves symptom management during and after radiation therapy, using problem-focused history and physical examination followed by appropriate symptomatic management as appropriate per treating physician's discretion. Intensive symptom management with monitoring patient reported outcomes is performed among patients with metastatic cancers receiving systemic therapies and with various cancers receiving radiation therapy. This trial may help researchers determine the impact of intensive symptom surveillance in patients with non-metastatic head and neck cancers.
详细描述
PRIMARY OBJECTIVE:
I. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom management on time to first acute care visits at 3 months.
SECONDARY OBJECTIVES:
I. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom management on (1) changes in health-related quality of life (HRQOL), financial burden, and caregiver burden from baseline, (2) time to first acute care visits at 1 or 6 month, (3) locoregional (LRF) and distant failure (DF), and (4) progression-free (PFS) and overall survival (OS) outcomes.
II. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom management when stratified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •PATIENTS: Age >= 18 years of age
- •PATIENTS: Diagnosed with biopsy-proven, non-metastatic squamous cell carcinoma of head and neck
- •PATIENTS: Scheduled to start curative-intent radiation therapy within 4 weeks
- •PATIENTS: Able to provide informed consent in English
- •PATIENTS: Able to read and write in English
- •PATIENTS: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related assessment
- •PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): They are verbally identified by eligible patients as a caregiver
- •PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): They are not receiving any payment to provide care for patients
- •PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): Able to provide informed consent in English
- •PATIENTS' INFORMED CAREGIVER (e.g. family members, friends): Able to read and write in English
排除标准
- •PATIENTS: Diagnosed with metastatic head and neck cancer
- •PATIENTS: Eligible for palliative-intent radiation therapy only
- •PATIENTS: Pregnant female participants
- •PATIENTS: Unwilling or unable to follow protocol requirements
- •PATIENTS: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate
研究组 & 干预措施
Group A (quality of life questionnaire)
Patients complete a quality of life questionnaires over 10-15 minutes BIW during standard of care radiation therapy and QW for the first month after completing standard of care radiation therapy course, and then once monthly for 6 months.
干预措施: Quality-of-Life Assessment (Other)
Group A (quality of life questionnaire)
Patients complete a quality of life questionnaires over 10-15 minutes BIW during standard of care radiation therapy and QW for the first month after completing standard of care radiation therapy course, and then once monthly for 6 months.
干预措施: Questionnaire Administration (Other)
Group B (standard symptom management)
Patients receive standard symptom management QW during standard of care radiation therapy and for 6 months after completing radiation therapy course.
干预措施: Palliative Therapy (Other)
结局指标
主要结局
Time to first acute care visit
时间窗: At 3 months
to evaluate the impact of intensive symptom evaluation compared to standard symptom management on time to first acute care visits at 3 months with time to first acute care visits.
次要结局
- Change in Health-related quality of life EORTC QLQ-C30(Baseline to 6 months)
- Overall survival(Time interval from diagnosis to death from any cause, assessed up to 6 months)
- Change in financial burden(Baseline to 6 months)
- Locoregional failure(Time interval from diagnosis to locoregional failure, assessed up to 6 months)
- Change in caregiver burden(Baseline to 6 months)
- Time to first acute care visits(At 1 or 6 month)
- Distant failure(Time interval from diagnosis to distant failure outside head and neck region, assessed up to 6 months)
- Progression free survival(Time interval from diagnosis to tumor recurrence or progression of disease, assessed up to 6 months)