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Fig 1.

Schedule of enrollment, interventions, and assessments.

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; ESAS, Edmonton Symptom Assessment System; EQ-5D-5L, EuroQol-5 Dimension-5 Level; mMRC, Modified Medical Research Council; NRS, numeric rating scale; RC, research coordinator; RT, respiratory therapist; SPOT-ON, Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology.*Patients will be followed for 30 days after end of treatment or until death, whichever occurs first.**Patients will start SPOT-ON after 72 hours of enhanced usual care if they still meet eligibility criteria at that time. ***Vital signs will be measured every 8 hours during the trial.

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Fig 1 Expand

Fig 2.

Study flow diagram.

Abbreviation: SPOT-ON, Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology.

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Fig 2 Expand

Table 1.

Blinding procedures in SPOT-ON randomized clinical trial.

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Table 1 Expand

Fig 3.

SPOT-ON study logistics.

Abbreviations: NRS, Numeric Rating Scale; RT, Respiratory Therapist. Respiratory therapists will identify preferred dyspnea treatment choices with individual patients based on time-limited trials and offer personalized use of oxygen using the specified modalities over the remaining 72 ± 4 hours.

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Fig 3 Expand

Table 2.

SPOT-ON device settings.

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Table 2 Expand

Table 3.

Comparison of traditional and personalized clinical trial design.

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Table 3 Expand