Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure: 1.Safety and adverse events (AEs)
研究概览
简要总结
To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer.
详细描述
Primary Objectives:
- To determine the effect of SPOT-ON and Enhanced Usual Care on the change in intensity of dyspnea (NRS) between baseline and 24 h in hypoxemic hospitalized patients with cancer.
- To determine the effect of SPOT-ON and Enhanced Usual Care on the change in intensity of dyspnea (NRS) between baseline and 24 h in non-hypoxemic hospitalized patients with cancer.
Secondary Objectives:
- To determine the effect of SPOT-ON and Enhanced Usual Care on patient outcomes over 72 h, including intensity of dyspnea (NRS), unpleasantness of dyspnea (NRS), dyspnea response, ital signs, symptom burden, health-related quality of life (EQ-5D-5L), adverse events, patterns of device use, and hospital outcomes.
- To identify factors associated with dyspnea response in the SPOT-ON intervention, including patient demographics, preferences, and level of usage of oxygen delivery modalities.
- To identify patient factors associated with their preferences (after Phase II and Phase III) for each of the oxygen delivery modalities in the SPOT-ON intervention, such as patient demographics and dyspnea characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of cancer
- •Age 18 or older.
- •Admitted to a medical floor.
- •Dyspnea intensity at rest of at least 4 on a 0-10-point NRS (where 0 = none, 10 = worst).
- •Speak English or Spanish.
排除标准
- •Hemodynamic instability requiring active Merit Team or ICU team involvement.
- •Delirium as per clinical team's assessment in the Electronic Health Record (EHR).
- •Severe hypoxemia (SpO2 < 90% despite supplemental oxygen of up to 6 L/min).
- •Continuous positive airway pressure (CPAP) use for obstructive sleep apnea, actively using >10 hours a day.
- •Respiratory failure necessitating mechanical ventilation (i.e., HFNC or NIV), and planned thoracentesis within 72 hours of enrollment.
- •Patients with known pregnancy.
研究组 & 干预措施
Group 1: SPOT-ON
Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.
干预措施: SPOT-ON Delayed Start (Behavioral)
Group 2: SPOT-ON Waitlist
Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.
干预措施: SPOT-ON Early Start (Behavioral)
Group 2: SPOT-ON Waitlist
Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.
干预措施: SPOT-ON Delayed Start (Behavioral)
Group 1: SPOT-ON
Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.
干预措施: SPOT-ON Early Start (Behavioral)
结局指标
主要结局
Primary Outcome Measure: 1.Safety and adverse events (AEs)
时间窗: [Time Frame: Through study completion; an average of 1 year.]
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
次要结局
未报告次要终点