Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Primary Outcome Measure: 1.Safety and adverse events (AEs)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: SPOT-ON Early 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.
Intervention: 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.
Intervention: 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.
Intervention: SPOT-ON Delayed Start (Behavioral)
Outcomes
Primary Outcomes
Primary Outcome Measure: 1.Safety and adverse events (AEs)
Time Frame: [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)
Secondary Outcomes
No secondary outcomes reported