PROJECT SUMMARY
Dyspnea is one of the most common and distressing symptoms associated with cancer, occurring in nearly 70%
of patients with advanced cancer. Dyspnea is associated with impaired function, decreased quality of life, and
shortened survival. Previous trials suggest that existing palliative interventions, such as low flow supplemental
oxygen and opioids, have limited efficacy. Due to the paucity of high-quality evidence, there are currently no U.S.
Food and Drug Administration (FDA)-approved treatment options. Multiple organizations, including the Institute
of Medicine and National Hospice and Palliative Nurses Association, identified dyspnea as a priority for research.
The long-term goal of our research is to develop evidence-based therapies for the palliation of dyspnea in
patients with cancer. The overall objective of our proposed high risk, high impact, two-arm, parallel-group, wait-
list control, randomized clinical trial is to compare the efficacy of a respiratory therapist (RT)-led Structured
Personalized Oxygen and support Therapies for dyspnea in ONcology patients (SPOT-ON) intervention with
enhanced usual care on dyspnea. Based on our preliminary data, we hypothesize that a personalized RT-led
intervention incorporating time-limited trials of oxygen and support therapies would be effective in reducing
dyspnea in acutely ill hospitalized patients with cancer. The two primary specific aims of this study are to compare
the effect of SPOT-ON and enhanced usual care on the change in intensity of dyspnea at 24 h in hospitalized
cancer patients with hypoxemia (Primary Aim 1) and without hypoxemia (Primary Aim 2). The third aim is to
compare the effect of SPOT-ON and enhanced usual care on patient outcomes over 72 h, including dyspnea
intensity, dyspnea unpleasantness, dyspnea response, vital signs, symptom burden, health-related quality of
life, adverse events, pattern of device use, and hospital outcomes. The fourth aim is to assess factors associated
with efficacy of the SPOT-ON intervention, including patient demographics, preferences, and level of usage of
oxygen delivery modalities. After obtaining informed consent, a RT will administer the structured study
interventions and monitor the participants closely for 72 hours.
This study is highly innovative because (1) it will be the first clinical trial to specifically examine a RT-led
intervention for palliation of dyspnea; (2) it will examine how time-limited trials can be used to personalize
dyspnea management; (3) it will provide treatment based on patient preference instead of physician prescription;
(4) it will test the effect of various oxygen modalities in patients without hypoxemia; (5) it adopts personalized
dyspnea goal as a novel response criteria; and (6) it employs an innovative personalized trial design. Successful
completion of this definitive study is expected to identify the optimal strategy to reduce dyspnea with oxygen-
based and support therapies. Results of this study are expected to enhance quality of life for patients with
advanced cancer, transform the management of dyspnea, and shift the paradigm of symptom research.
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