Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
ConditionDyspnea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
SPOT-ON Early Start
BehavioralParticipants 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.
SPOT-ON Delayed Start
BehavioralParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Group 1: SPOT-ONExperimental treatment 2 interventions
Group B: Group 2: SPOT-ON WaitlistExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Primary Outcome Measure: 1.Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame
[Time Frame: Through study completion; an average of 1 year.]Sponsors and contacts
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Source ClinicalTrials.gov