Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology

Dyspnea Clinical Trial

Official title:

Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336642
• Other study ID #: 2023-0933
• Secondary ID: NCI-2024-02452
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 11, 2024
• Est. completion date: March 31, 2032

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: David Hui, MD
• Phone: (713) 792-6258
• Email: dhui[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2032
• Est. primary completion date: March 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Dyspnea

Intervention

Behavioral:
• SPOT-ON Early Start
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.
• SPOT-ON Delayed Start
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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Through study completion; an average of 1 year.]

External Links

•   MD Anderson Cancer Center Website