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

NCT04851639 | Unknown

• 1 other identifier: 284454
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 patient some sense of agency and control and to inform his clinician of just he feels he is coping with his treatment. Now the investigators want to find out just how the results from WATapp correspond to, for example, changes in the patient's 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.

Conditions

Advanced Prostate Carcinoma

Keywords

metastatic; quality of life; patient empowerment

Outcome Measures

Primary Outcomes (1)

• WATapp as a proxy for patients' clinical status

  The correlation between the patient's responses to WATapp and their clinical status as measured by routine bloods and clinician assessment.

  up to 48 months

Study Arms (1)

Proof of principle

EXPERIMENTAL

Proof of principle of the efficacy and utility of the WATapp

Other: Wolverhampton Assessment Tool

Interventions

Wolverhampton Assessment Tool OTHER

a proxy means for assessing whether clinician intervention is required and to assess patient's lived quality of life

Proof of principle

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wolverhampton: lead
• The Royal Wolverhampton Hospitals NHS Trust: collaborator

Study Sites (1)

Royal Wolverhampton Hospital NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Patient Participation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David Matheson, PhD

  University of Wolverhampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Matheson, PhD

CONTACT

+447469882072; d.matheson@wlv.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: any patient with advanced or metastatic prostate cancer

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 20, 2021
• Study Start: September 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: March 30, 2025
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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

Locations

GB (1)