Clinical trial NCT06334913: A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms
Official title: A Prospective Digital Monitoring Project Exploring Physical Activity, Patient Reported Outcome Measures and Disease Outcomes in Individuals With Myeloproliferative Neoplasms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myeloproliferative Neoplasm
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: U.K. based adult patients with diagnosis of MPN.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score
timeFrame: 5 years
Secondary outcomes:
measure: Healthcare adherence
timeFrame: 5 years
measure: Biometric data analysis - activity index
timeFrame: 5 years
measure: Biometric data analysis - sleep score
timeFrame: 5 years
measure: Biometric data analysis - heart rate
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Patrick Harrington, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: