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Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology

Recruiting
18 years of age
Both
Phase 2/3

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Overview

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.

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

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 >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.

Study details

Dyspnea

NCT06336642

M.D. Anderson Cancer Center

26 June 2024

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