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Trial Title:
Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
NCT ID:
NCT06336642
Condition:
Dyspnea
Conditions: Official terms:
Dyspnea
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
SPOT-ON Early Start
Description:
Participants 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.
Arm group label:
Group 1: SPOT-ON
Arm group label:
Group 2: SPOT-ON Waitlist
Intervention type:
Behavioral
Intervention name:
SPOT-ON Delayed Start
Description:
Participants 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.
Arm group label:
Group 1: SPOT-ON
Arm group label:
Group 2: SPOT-ON Waitlist
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.
Criteria for 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 >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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Hui, MD
Phone:
713-792-6258
Email:
dhui@mdanderson.org
Start date:
June 11, 2024
Completion date:
March 31, 2032
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06336642
http://www.mdanderson.org