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Remote Monitoring of Cancer Patients With Suspected Covid-19 (RECAP)

9 febbraio 2021 aggiornato da: The Christie NHS Foundation Trust

Remote Monitoring of Cancer Patients Presenting With Symptoms Suggestive of Covid-19 - Pilot Phase.

Since emerging in December 2019, coronavirus disease 2019 (Covid-19) has developed into an unprecedented global pandemic. The causative pathogen, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has the potential to cause a wide range of clinical syndromes, from fever, dyspnoea and cough to respiratory failure and cardiac injury necessitating critical care support. A number of patients have a more indolent clinical course and can be safely managed in the community.

Characterising the clinical course of Covid-19 infection in the oncology population and distinguishing this from other acute oncology presentations which can mimic Covid-19 is a key unmet research need. Current standard of care for monitoring patients at high risk of chemotherapy associated neutropenic sepsis involves asking them to contact their cancer centre when they feel unwell or develop a fever. No standard of care for monitoring ambulatory Covid-19 patients has yet been established. We hypothesise that using wearable biosensors to detect patients who exhibit 'red flags' for sepsis or deterioration due to Covid-19 may allow earlier assessment and intervention. There is no current evidence for wearable biosensors in ambulatory patients receiving chemotherapy, and there is no existing research into this proposed use of biosensors in patients with suspected or confirmed Covid-19 infection.

In order to justify performing a randomised controlled study comparing standard of care with biosensor driven monitoring it is important to establish the tolerability and validity of these devices. We aim to collect patient reported outcome measures (PROMs) on tolerability and assess the reliability of data transmission to a central data collection server. We will also perform an initial analysis of physiological data and correlation with clinical events

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a pilot, single arm, open label feasibility study. This is a single centre trial based in a large tertiary cancer centre which treats patients across all solid and haematological malignancies. Patients will be recruited from all disease groups.

Patients who present with symptoms suspicious for Covid-19 who the admitting clinicians deems appropriate for outpatient management will be considered for this study.

Patients who are enrolled will undergo continuous physiological monitoring for up to three weeks. This includes continuous monitoring of heart rate, respiratory rate, temperature, activity levels (by accelerometer measurement) and twice daily pulse oximetry. The physiological data will not be reviewed in real time by clinicians and therefore will not be used to alter patients' standard care. The pulse oximetry data will be visible to patients who will be given clear guidelines to follow with regards to contacting the cancer centre hotline should values deviate from baseline.

In the pilot phase of RECAP 10-30 patients will each be monitored for up to 3 weeks and the following endpoints will be addressed:

Physiological trends and interactions predictive of clinical deterioration due to COVID-19 (Co-primary endpoint) Reliability of biosensor data collection/transmission using digital technology from patients self-isolating at home (Co-primary endpoint) Acceptability and tolerability of wearable biosensors and continuous monitoring If the pilot phase is successful we will move to a phase II study in a larger number of patients where the objective will be to refine a physiological signature predictive of clinical deterioration in COVID-19 patients so that early hospitalisation and relevant medical interventions can be arranged.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

30

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Regno Unito
    • Greater Manchester
      • Manchester, Greater Manchester, Regno Unito, M204BX
        • Reclutamento
        • The Christie Nhs Foundation Trust
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Participants are capable of giving informed consent
  2. Male or female aged 18 or over

  3. Diagnosis of any solid tumour or haematological malignancy meeting one of the following criteria:

    • Current malignant diagnosis
    • Received anti-cancer treatment within the last two years
  4. Emergency presentation to hospital with symptoms consistent with Covid-19 deemed to meet the criteria for Covid-19 testing by admitting clinician.
  5. Deemed by the admitting clinician to be suitable for outpatient management of suspected Covid-19.
  6. Stable oxygen saturations of 95% or higher at time of emergency presentation.
  7. Able to complete tolerability questionnaire.
  8. Able and willing to comply with twice daily pulse oximetry monitoring as outlined in section 6 of the protocol.
  9. ECOG-PS <4
  10. Life expectancy of greater than three months as assessed by screening investigator from review of electronic patient record.

Exclusion Criteria:

  1. Patients hospitalized for more than 24 hours at initial presentation with symptoms consistent with Covid-19.
  2. Pregnant patients.
  3. Patients unable to give informed consent.
  4. Presence of ulceration or pre-existing skin rash at site of device application (left precordium and axillae). If only one axilla affected this is not an exclusion criterion if patient is happy to apply temperature sensor to the other axilla.
  5. Radiotherapy to the left chest wall either during or within the six months preceding the study. Plans for subsequent radiotherapy to commence after study completion are not an exclusion criterion. If only one axilla is within the planned radiotherapy field and patient is happy to apply temperature sensor to the other axilla this is not an exclusion criteria.
  6. History of allergy or contact dermatitis to medical adhesives e.g sticking plasters, ECG electrodes.
  7. Patients with pacemakers, implantable defibrillators or neurostimulators.
  8. Patients who are currently receiving treatment as part of a clinical study or have had their end of treatment visit for another clinical study less than 30 days prior to the study enrollment visit.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Ambulatory monitoring
Participants will be asked to wear the sensors (heart rate, respiratory rate, temperature, and pulse oximetry) for three weeks. Data will be collected from the devices but will only be reviewed retrospectively and will not be used to alter participants care.
Dispositivo: Patient Status Engine
Wearable sensors

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Device Tolerability (Attrition)
Lasso di tempo: Three weeks
Percentage of patients who choose to stop wearing the devices before they have completed the study
Three weeks
Correlation of physiological data with clinical events
Lasso di tempo: Over three weeks of patients wearing devices
Correlation of sensor collected data with clinical episodes of infection. Sensor collected data includes heart rate, respiratory rate and temperature.
Over three weeks of patients wearing devices

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Device Tolerability (Questionnaire)
Lasso di tempo: Questionnaire at three weeks
Percentage of participants who answer 'agree' or 'strongly agree' on a five point Likert scale to the statement 'I would be happy to wear the sensors again for the next three weeks'. This statement is included in the questionnaires completed after three weeks of wearing the device.
Questionnaire at three weeks
Device Tolerability (Semi-structured interviews)
Lasso di tempo: One to four weeks after completion of wearing the device
Device tolerability as assessed by semi-structured interviews.
One to four weeks after completion of wearing the device
Reliability of data transmission
Lasso di tempo: Over three weeks of patients wearing devices
Reliable data transmission to central hospital system expressed as a percentage of total data points collected out of target data points collected.
Over three weeks of patients wearing devices

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Christie NHS Foundation Trust

Investigatori

  • Investigatore principale: John Radford, The University of Manchester

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 ottobre 2020

Completamento primario (Anticipato)

1 aprile 2021

Completamento dello studio (Anticipato)

1 aprile 2021

Date di iscrizione allo studio

Primo inviato

20 maggio 2020

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2020

Primo Inserito (Effettivo)

21 maggio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 febbraio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 febbraio 2021

Ultimo verificato

1 febbraio 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CFTSp186

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Descrizione del piano IPD

The physiological data represents a rich clinical data resource which has the potential to be valuable in other contexts to answer future unanticipated questions. We therefore propose storing this pseudoanonymised data in a Data Bank with a lifespan initially of five years with potential for extension if appropriate ethical approval is gained. This Data Bank could then be used, under ethical approval for other research in order to maximise the potential utility of the data.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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 .

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