M.D. Anderson Cancer Center
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.
Dyspnea
SPOT-ON Early Start
SPOT-ON Delayed Start
Phase 2
Phase 3
Primary Objectives: 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. 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: 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. To identify factors associated with dyspnea response in the SPOT-ON intervention, including patient demographics, preferences, and level of usage of oxygen delivery modalities. 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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 150 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Supportive Care |
| Official Title : | Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology |
| Actual Study Start Date : | September 30, 2024 |
| Estimated Primary Completion Date : | March 31, 2030 |
| Estimated Study Completion Date : | March 31, 2032 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group 1: SPOT-ON Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team. |
Behavioral: SPOT-ON Early Start Behavioral: SPOT-ON Delayed Start |
|
Experimental: Group 2: SPOT-ON Waitlist Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team. |
Behavioral: SPOT-ON Early Start Behavioral: SPOT-ON Delayed Start |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, United States, 77030