Terapie personalizzate strutturate di ossigeno e di supporto per la dispnea in oncologia
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: David Hui, MD
- Numero di telefono: (713) 792-6258
- Email: dhui@mdanderson.org
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- MD Anderson Cancer Center
-
Contatto:
- David Hui, MD
- Numero di telefono: 713-792-6258
- Email: dhui@mdanderson.org
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of cancer
- 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, actively using >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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
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. 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. |
|
Sperimentale: 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. |
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. 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Primary Outcome Measure: 1.Safety and adverse events (AEs)
Lasso di tempo: [Time Frame: Through study completion; an average of 1 year.]
|
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.]
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: David Hui, MD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2023-0933
- NCI-2024-02452 (Altro identificatore: NCI-CTRP Clinical Trials Registry)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .