Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334913
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
A Prospective Digital Monitoring Project Exploring Physical Activity Patient Reported Outcome Measures and Disease Outcomes in Individuals With Myeloproliferative Neoplasms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The investigators will assess the use of a smart phone app to monitor patient reported outcomes and record biometric data in patients with myeloproliferative neoplasms
Detailed Description:
To determine whether the development of a dedicated myeloproliferative neoplasm MPN smartphone application is of benefit to MPN patients and shows utility for medical professionals to explore efficient disease management through retrieval of real-world patient data
1 To Track Symptoms and Provide Easy Access to Information The core focus of the project is to enhance the quality of life for people with MPNs The app will serve as a comprehensive toolkit to help people with MPNs proactively monitor and track their symptoms leading to improved self-care The App will also provide direct access to reliable up-to-date information about MPNs empowering users to better understand their condition and make well-informed decisions regarding their health
2 To Contribute to Research The app will actively contribute to MPN research by generating valuable patient-generated real-world data to inform clinical trials treatment development and disease understanding Currently most of the clinical information and data in this patient population comes from clinical trials and major academic centres As such there is a significant gap in recording practice and outcomes in other areas which likely makes up a large proportion of the total patient population The app would provide a means of monitoring patient experience comorbidities treatments and outcomes as well as highlighting unmet needs in this under-represented patient group
A 5-year sub-study using wearables is also planned to explore symptom management and collect biometric data to assess how this correlates with symptom burden disease specific outcomes treatment response and quality of life The apps data collection capabilities have the potential to revolutionize the research landscape for MPNs By collecting large volume data from this patient group researchers will be able to assess trends in treatment response biomarker identification and allow optimisation of therapeutic pathways and improve design of clinical trials This could lead to the development of new treatments being made more widely available to patients and potentially improve the lives of this patient population
1 To Track Symptoms and Provide Easy Access to Information The core focus of the project is to enhance the quality of life for people with MPNs The app will serve as a comprehensive toolkit to help people with MPNs proactively monitor and track their symptoms leading to improved self-care The App will also provide direct access to reliable up-to-date information about MPNs empowering users to better understand their condition and make well-informed decisions regarding their health
2 To Contribute to Research The app will actively contribute to MPN research by generating valuable patient-generated real-world data to inform clinical trials treatment development and disease understanding Currently most of the clinical information and data in this patient population comes from clinical trials and major academic centres As such there is a significant gap in recording practice and outcomes in other areas which likely makes up a large proportion of the total patient population The app would provide a means of monitoring patient experience comorbidities treatments and outcomes as well as highlighting unmet needs in this under-represented patient group
A 5-year sub-study using wearables is also planned to explore symptom management and collect biometric data to assess how this correlates with symptom burden disease specific outcomes treatment response and quality of life The apps data collection capabilities have the potential to revolutionize the research landscape for MPNs By collecting large volume data from this patient group researchers will be able to assess trends in treatment response biomarker identification and allow optimisation of therapeutic pathways and improve design of clinical trials This could lead to the development of new treatments being made more widely available to patients and potentially improve the lives of this patient population
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?:
False
Is an FDA AA801 Violation?:
None