Dyspnea
Conditions
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: 1. 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. 2. 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: 1. 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. 2. To identify factors associated with dyspnea response in the SPOT-ON intervention, including patient demographics, preferences, and level of usage of oxygen delivery modalities. 3. 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.
Interventions
BEHAVIORALSPOT-ON Early Start
Participants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist.
BEHAVIORALSPOT-ON Delayed Start
Participants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure: 1.Safety and adverse events (AEs) | [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) |
Countries
United States
Contacts
CONTACTDavid Hui, MD
PRINCIPAL_INVESTIGATORDavid Hui, MD
M.D. Anderson Cancer Center
Outcome results
None listed