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The Wolverhampton Assessment Tool, a Tool for Patient-reported Wellbeing in the Context of Prostate Cancer (WATapp)

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ClinicalTrials.gov Identifier: NCT04851639
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
The Royal Wolverhampton Hospitals NHS Trust
Information provided by (Responsible Party):
Dr David Matheson, University of Wolverhampton

Brief Summary:

This is a study of the Wolverhampton Assessment Tool (WATapp), a five-item questionnaire for patients with advanced or metastatic prostate cancer to say how they feel normally in terms of pain, urinary frequency, eating, and tiredness. It is widely recognised that patient-reported outcomes give a measure of overall effect of clinicians' actions on patients and that they can be used to guide the management of the patient's condition.

WATapp is designed to reduce the need for the patient to attend hospital so much for routine follow-up consultations (an important aspect in light of COVID-19), to give the man some sense of agency and control and to inform his clinician of just he feels he is coping with his treatment. Now we want to find out just how the results from WATapp correspond to, for example, changes in PSA, testosterone or other blood results which are routinely measured; and to find out how patients and clinicians feel about using WATapp.

Men with advanced or metastatic prostate cancer will be eligible to take part in the study and participation is in addition to whatever treatment they are on. Clinicians who choose to offer WATapp to their patients will also be invited to take part and they will be asked to share with the researchers anonymised, linked patient data and scores from WATapp.


Condition or disease Intervention/treatment Phase
Advanced Prostate Carcinoma Other: Wolverhampton Assessment Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: any patient with advanced or metastatic prostate cancer
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Wolverhampton Assessment Tool, a Step Towards Remote Monitoring of Patient-reported Wellbeing in the Context of Prostate Cancer
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : March 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Proof of principle
Proof of principle of the efficacy and utility of the WATapp
Other: Wolverhampton Assessment Tool
a proxy means for assessing whether clinician intervention is required and to assess patient's lived quality of life




Primary Outcome Measures :
  1. WATapp as a proxy for patients' clinical status [ Time Frame: up to 48 months ]
    The correlation between the patient's responses to WATapp and their clinical status as measured by routine bloods and clinician assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • born male
  • diagnosed with advanced or metastatic prostate cancer
  • able to read and speak English

Exclusion Criteria:

  • not born male
  • not diagnosed with advanced or metastatic prostate cancer
  • not able to read and speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851639


Contacts
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Contact: David Matheson, PhD +447469882072 d.matheson@wlv.ac.uk

Locations
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United Kingdom
Royal Wolverhampton Hospital NHS Trust Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Ian Sayers, MBBS    07789935567    iansayers@nhs.net   
Sponsors and Collaborators
University of Wolverhampton
The Royal Wolverhampton Hospitals NHS Trust
Investigators
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Principal Investigator: David Matheson, PhD University of Wolverhampton
  Study Documents (Full-Text)

Documents provided by Dr David Matheson, University of Wolverhampton:
Study Protocol  [PDF] May 11, 2020

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Responsible Party: Dr David Matheson, Reader in education for health, University of Wolverhampton
ClinicalTrials.gov Identifier: NCT04851639    
Other Study ID Numbers: 284454
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The IPD plan is in development. It is expected that it will include

  • Study protocol
  • Information sheets and blank informed consent forms
  • Anonymised data from the study

Sharing will be subject to application, guarantees as to usage, due recognition of source

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will become available once we have published our results and for two years thereafter.
Access Criteria: Data will be available to bona fide researchers with good reason such as conducting meta-analyses

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr David Matheson, University of Wolverhampton:
metastatic
quality of life
patient empowerment
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases