Myeloproliferative NeoplasmNCT06334913
A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms
An observational study of Myeloproliferative Neoplasm, run by Guy's and St Thomas' NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: U.K. based adult patients with diagnosis of MPN.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amna Sheikh contact
About this study
Official title: 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.
Read the 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.
- 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.
- 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.
- Conditions
- Myeloproliferative Neoplasm
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MPN patients | U.K. based adult patients with MPN diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
Healthcare adherence
To determine the association between patients' adherence to medication, number of hospital attendances and admissions, and data from the wearables.
Measured: 5 years
Biometric data analysis - activity index
Wearable device tracking activity index (calories)
Measured: 5 years
Biometric data analysis - sleep score
Wearable device tracking sleep score (0-100)
Measured: 5 years
Biometric data analysis - heart rate
Wearable device tracking heart rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Harrington, MBBS PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334913
- Sponsor's protocol ID
- IRAS 332286
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plans to share patient data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Digital Monitoring Project Exploring Physical Activity, Patient Reported Outcome Measures and Disease Outcomes in Individuals With Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT06334913
- Acronym / sponsor ID
- IRAS 332286
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPN patients | – | –U.K. based adult patients with MPN diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- U.K. based adult patients with diagnosis of MPN.
Key inclusion criteria (7 listed)
- Diagnosis of MPN.
- Resident in the UK
- Aged 18 years and over.
- Able to confidently converse in English language.
- Access to smartphone/ mobile phone.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score
Time frame: 5 years
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.
4 secondary outcomes
Healthcare adherence
Time frame: 5 years
Biometric data analysis - activity index
Time frame: 5 years
Biometric data analysis - sleep score
Time frame: 5 years
Biometric data analysis - heart rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No. No current plans to share patient data with other researchers.
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RecruitingPhase 2
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Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amna Sheikh contact
Patrick Harrington, MBBS PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Harrington, MBBS PhD (+447946509718, patrick.harrington@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.