A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myeloproliferative Neoplasm

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 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Patrick Harrington, MBBS PhD; Phone Number: +447946509718; Email: patrick.harrington@gstt.nhs.uk
• Study Contact Backup: Name: Amna Sheikh; Email: amna.sheikh@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

U.K. based adult patients with diagnosis of MPN.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MPN patients; U.K. based adult patients with MPN diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare adherence	To determine the association between patients' adherence to medication, number of hospital attendances and admissions, and data from the wearables.	5 years
Biometric data analysis - activity index	Wearable device tracking activity index (calories)	5 years
Biometric data analysis - sleep score	Wearable device tracking sleep score (0-100)	5 years
Biometric data analysis - heart rate	Wearable device tracking heart rate	5 years

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Patrick Harrington, MBBS PhD, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Neoplasms; Myeloproliferative Disorders
• Other Study ID Numbers: IRAS 332286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plans to share patient data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No