OncologyNCT05478135
A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation
A study testing NAVIFY Oncology Hub in people with Oncology, run by Prova Health Limited at 1 site in United Kingdom.
Trial summary
This work seeks to understand current clinical workflow practice and validate use cases for NAVIFY Oncology Hub. The main purpose of NAVIFY Oncology Hub is to enhance clinical and operational effectiveness, from diagnostic workup to treatment planning and management. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- NAVIFY Oncology Hub
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2022to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Board-certified, US-based oncologist
- Minimum 50% spent in clinical practice
- Active member of a tumor board
Who cannot join
- Experience using NAVIFY Oncology Hub
- Inability to speak English
Trial locations and contacts
1 site in 1 country.
About this study
This work seeks to understand current clinical workflow practice and validate use cases for NAVIFY Oncology Hub.
The main purpose of NAVIFY Oncology Hub is to enhance clinical and operational effectiveness, from diagnostic workup to treatment planning and management. This might free up providers' time and capacity to provide better and more personalized care to patients.
Read more
This research protocol builds on previous work that validated clinical simulation methods as a means for clinicians to generate useful insights during the testing and development of digital health tools (Gardner et al. 2020).
Accordingly, this study aims to test the ability of NAVIFY Oncology Hub to increase the work efficiency of oncologists and reduce the cognitive burden/mental fatigue associated with patient care and decision-making.
The insights generated will be used to guide the development of NAVIFY Oncology Hub and optimise user experience, as well as provide a better understanding of the opportunities for it to have maximal impact in the decision-making process.
Read the detailed description
NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly.
Clinical workflow is critical for the efficient and safe delivery of patient care. In most healthcare settings, clinical workflow is highly complex, and reflects the multidisciplinary collaboration and communication required of most clinical tasks. Studies have demonstrated a positive association between leveraging health information technology workflow tools for care coordination and patient engagement, and improved process quality metrics in preventive screening, diabetes control, as well as maternal and child health (Kruse \& Bean 2018; Kranz et al. 2018). Embedded decision support tools have also been proven to improve the performance of risk assessments conducted by providers, as well as enhance patient safety and decrease mortality (Chaudhry et al. 2006; Wells et al. 2008; Jones et al. 2014; Campanella et al. 2015).
A set of 10 synthetic breast cancer patient cases will be developed by Prova Health. Cases will include history and examination findings, pathology reports, radiology reports and images (USS, mammogram, CT as applicable) and reports on tumor characteristics. The case details will be representative of a long term patient journey, inclusive of treatment lines such as adjuvant and neoadjuvant therapies. Cases will be selected to span the range of potential case scenarios seen in typical practice. Specifically, cases will be selected to include common invasive breast cancers (eg. IDC, ILC), as well as less common invasive breast cancers (eg. inflammatory). Cases will also represent a range of cancers with different molecular subtypes, such as whether the patient is HER2 positive or negative, hormone receptor (HR) positive or negative or triple negative. Finally, cases will also reflect the presentation of patients at various stages (eg. primary diagnosis, locally and regional advanced breast cancer, recurrent breast cancer, or metastatic advanced breast cancer).
Each participant will participate in a 90-minute remote (e.g., online) simulation session. During scheduling, participants will be given a link to use to join the session. This link will take them to a video conference call hosted through Google Meet. At the session, the moderator will facilitate the session and take notes.
Participants will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting. This task will involve searching for, identifying, reviewing and synthesizing relevant clinical information (demographic information, pathology reports, clinical course, etc.) that supports decision-making. As such, this task is meant to simulate the same activities they would perform in their typical practice before inviting a patient into the clinic room for a consultation, and will permit this study to examine the usage of NAVIFY Oncology Hub on those activities.
Ultimately, the aim of the study is to investigate how NAVIFY Oncology Hub improves efficiency and reduces cognitive burden associated with reviewing and synthesizing patient information, and having participants engage with the platform requires them to go through those tasks.
- Conditions
- Oncology
- Being tested
- NAVIFY Oncology Hub
- Keywords
- Digital Health, Health tech, Clinical simulation, Healthcare technology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVIFY Oncology HubDevice
NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly.
| Study group | Role | What they receive |
|---|---|---|
| NAVIFY Oncology Hub | Experimental | We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting. Receives: Device: NAVIFY Oncology Hub |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
The System Usability Scale (SUS) a reliable tool for measuring the usability. It consists of a 10-item questionnaire with five response options for respondents; from Strongly disagree to Strongly agree. The participant's scores for each question added together and multiplied by 2.5 to convert the original scores of 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Measured: 90 mins
Participant-reported Efficiency When Preparing for Patient Consultations, Likert Scale
Count of participants self-reporting that they were "a lot more efficient" or "somewhat more efficient" when using navify Oncology Hub to review patient information.
Measured: 90 mins
NASA Task Load Index (NASA-TLX)
Number of participants who required "low" or "very low" levels of mental demand, temporal demand, and effort to successfully complete tasks using NAVIFY Oncology Hub.
Measured: 90 mins
Participant-reported Efficacy of Using Navify Oncology Hub to Facilitate Patient Discussions and Collaborate Care
Number of participants self-reporting who felt nOH would be "significantly better" or "somewhat better" than their existing solution at facilitating patient discussion and coordinating care.
Measured: 90 mins
Participant-reported Fidelity of Synthetic Patient Cases
Number of participants self-reporting that the synthetic patient cases were either 'very similar' or 'somewhat similar' to cases seen in routine clinical practice
Measured: 90 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start15 May 2022
- Primary completion22 Oct 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prova Health Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Saira J Ghafur, MD, Principal investigator, Prova Health Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478135
- Sponsor's protocol ID
- HLR-NOH-001
- Status last verified
- Nov 2024
- First submitted
- 22 Jul 2022
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share IPD
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation
- ClinicalTrials.gov ID
- NCT05478135
- Acronym / sponsor ID
- HLR-NOH-001
- Conditions
- Oncology
- Keywords
- Digital Health, Health tech, Clinical simulation, Healthcare technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Prova Health LimitedUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 15 May 2022 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work seeks to understand current clinical workflow practice and validate use cases for NAVIFY Oncology Hub.
The main purpose of NAVIFY Oncology Hub is to enhance clinical and operational effectiveness, from diagnostic workup to treatment planning and management. This might free up providers' time and capacity to provide better and more personalized care to patients.
This research protocol builds on previous work that validated clinical simulation methods as a means for clinicians to generate useful insights during the testing and development of digital health tools (Gardner et al. 2020).
Accordingly, this study aims to test the ability of NAVIFY Oncology Hub to increase the work efficiency of oncologists and reduce the cognitive burden/mental fatigue associated with patient care and decision-making.
The insights generated will be used to guide the development of NAVIFY Oncology Hub and optimise user experience, as well as provide a better understanding of the opportunities for it to have maximal impact in the decision-making process.
Detailed description
NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly.
Clinical workflow is critical for the efficient and safe delivery of patient care. In most healthcare settings, clinical workflow is highly complex, and reflects the multidisciplinary collaboration and communication required of most clinical tasks. Studies have demonstrated a positive association between leveraging health information technology workflow tools for care coordination and patient engagement, and improved process quality metrics in preventive screening, diabetes control, as well as maternal and child health (Kruse \& Bean 2018; Kranz et al. 2018). Embedded decision support tools have also been proven to improve the performance of risk assessments conducted by providers, as well as enhance patient safety and decrease mortality (Chaudhry et al. 2006; Wells et al. 2008; Jones et al. 2014; Campanella et al. 2015).
A set of 10 synthetic breast cancer patient cases will be developed by Prova Health. Cases will include history and examination findings, pathology reports, radiology reports and images (USS, mammogram, CT as applicable) and reports on tumor characteristics. The case details will be representative of a long term patient journey, inclusive of treatment lines such as adjuvant and neoadjuvant therapies. Cases will be selected to span the range of potential case scenarios seen in typical practice. Specifically, cases will be selected to include common invasive breast cancers (eg. IDC, ILC), as well as less common invasive breast cancers (eg. inflammatory). Cases will also represent a range of cancers with different molecular subtypes, such as whether the patient is HER2 positive or negative, hormone receptor (HR) positive or negative or triple negative. Finally, cases will also reflect the presentation of patients at various stages (eg. primary diagnosis, locally and regional advanced breast cancer, recurrent breast cancer, or metastatic advanced breast cancer).
Each participant will participate in a 90-minute remote (e.g., online) simulation session. During scheduling, participants will be given a link to use to join the session. This link will take them to a video conference call hosted through Google Meet. At the session, the moderator will facilitate the session and take notes.
Participants will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting. This task will involve searching for, identifying, reviewing and synthesizing relevant clinical information (demographic information, pathology reports, clinical course, etc.) that supports decision-making. As such, this task is meant to simulate the same activities they would perform in their typical practice before inviting a patient into the clinic room for a consultation, and will permit this study to examine the usage of NAVIFY Oncology Hub on those activities.
Ultimately, the aim of the study is to investigate how NAVIFY Oncology Hub improves efficiency and reduces cognitive burden associated with reviewing and synthesizing patient information, and having participants engage with the platform requires them to go through those tasks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAVIFY Oncology Hub | Experimental | Device: NAVIFY Oncology HubWe will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Board-certified, US-based oncologist
- Minimum 50% spent in clinical practice
- Active member of a tumor board
Key exclusion criteria (2 listed)
- Experience using NAVIFY Oncology Hub
- Inability to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVIFY Oncology HubNAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly. | Device | NAVIFY Oncology Hub |
Primary outcome
System Usability Scale (SUS)
Time frame: 90 mins
The System Usability Scale (SUS) a reliable tool for measuring the usability. It consists of a 10-item questionnaire with five response options for respondents; from Strongly disagree to Strongly agree. The participant's scores for each question added together and multiplied by 2.5 to convert the original scores of 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Participant-reported Efficiency When Preparing for Patient Consultations, Likert Scale
Time frame: 90 mins
Count of participants self-reporting that they were "a lot more efficient" or "somewhat more efficient" when using navify Oncology Hub to review patient information.
NASA Task Load Index (NASA-TLX)
Time frame: 90 mins
Number of participants who required "low" or "very low" levels of mental demand, temporal demand, and effort to successfully complete tasks using NAVIFY Oncology Hub.
Participant-reported Efficacy of Using Navify Oncology Hub to Facilitate Patient Discussions and Collaborate Care
Time frame: 90 mins
Number of participants self-reporting who felt nOH would be "significantly better" or "somewhat better" than their existing solution at facilitating patient discussion and coordinating care.
Participant-reported Fidelity of Synthetic Patient Cases
Time frame: 90 mins
Number of participants self-reporting that the synthetic patient cases were either 'very similar' or 'somewhat similar' to cases seen in routine clinical practice
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This study will not share IPD
Related trials for Oncology
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saira J Ghafur, MD principal investigator
Prova Health Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVIFY Oncology Hub in people with Oncology, run by Prova Health Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: 90 mins). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.