A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms

Myeloproliferative Neoplasm Clinical Trial

Official title:

A Prospective Digital Monitoring Project Exploring Physical Activity, Patient Reported Outcome Measures and Disease Outcomes in Individuals With Myeloproliferative Neoplasms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334913
• Other study ID #: IRAS 332286
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2029

Study information

• Verified date: March 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Patrick Harrington, MBBS PhD
• Phone: +447946509718
• Email: patrick.harrington[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 app's 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of MPN.

2. Resident in the UK

3. Aged 18 years and over.

4. Able to confidently converse in English language.

5. Access to smartphone/ mobile phone.

6. Capable of providing informed consent.

7. Physically able to stand and ambulate independently (for substudy).

Exclusion Criteria:

• Patients with a known allergic reaction to any materials in the wearable device (substudy).

• Patients who for any reason are not able to have a wearable (substudy). For example Withings ScanWatch should not be be used if the patient has an implantable electronic device such as a pacemaker or implantable cardioverter-defibrillator

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score	The primary outcome of this study will be to characterise a baseline of healthcare data, patient reporting of symptom burden (as per MPN 10 symptom assessment form, raneg 0-100, higher scores indicative of greater symptom burden) to understand its relevance for disease-specific clinical outcomes.	5 years
Secondary	Healthcare adherence	To determine the association between patients' adherence to medication, number of hospital attendances and admissions, and data from the wearables.	5 years
Secondary	Biometric data analysis - activity index	Wearable device tracking activity index (calories)	5 years
Secondary	Biometric data analysis - sleep score	Wearable device tracking sleep score (0-100)	5 years
Secondary	Biometric data analysis - heart rate	Wearable device tracking heart rate	5 years