Clinical trial NCT06336642: Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
Official title: Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Dyspnea
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced cancer (metastatic, locally advanced, recurrent, or incurable).
* 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.

Primary outcomes:
measure: Primary Outcome Measure: 1.Safety and adverse events (AEs)
timeFrame: [Time Frame: Through study completion; an average of 1 year.]
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui, MD
role: PRINCIPAL_INVESTIGATOR
References: