Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336642
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-20
Brief Title:
Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02452 | OTHER | NCI-CTRP Clinical Trials Registry | None |