A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms

NCT06334913 | Not Yet Recruiting DMC

• 1 other identifier: IRAS 332286
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Healthcare adherence

  5 years

• Biometric data analysis - activity index

  5 years

• Biometric data analysis - sleep score

  5 years

• Biometric data analysis - heart rate

  5 years

Study Arms (1)

MPN patients

U.K. based adult patients with MPN diagnosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of MPN.
• Resident in the UK
• Aged 18 years and over.
• Able to confidently converse in English language.
• Access to smartphone/ mobile phone.
• Capable of providing informed consent.
• Physically able to stand and ambulate independently (for substudy).

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Patrick Harrington, MBBS PhD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Harrington, MBBS PhD

CONTACT

+447946509718; patrick.harrington@gstt.nhs.uk

Amna Sheikh

CONTACT

amna.sheikh@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 28, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share