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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-02452 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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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.
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: SPOT-ON | Experimental | 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. |
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| Group 2: SPOT-ON Waitlist | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPOT-ON Early Start | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Hui, MD | Contact | (713) 792-6258 | dhui@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| David Hui, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41329762 | Derived | Hui D, Kim MJ, Thomas S, Sachdev G, Shete S, Rathi N, Hensch N, De La Cruz V, Ontai A, Mahler DA, Li J, Bruera E. Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON): A personalized randomized clinical trial protocol. PLoS One. 2025 Dec 2;20(12):e0336691. doi: 10.1371/journal.pone.0336691. eCollection 2025. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2024 | Jan 31, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| SPOT-ON Delayed Start | Behavioral | 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. |
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| D013568 | Pathological Conditions, Signs and Symptoms |