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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

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