The Wolverhampton Assessment Tool, a Tool for Patient-reported Wellbeing in the Context of Prostate Cancer
The Wolverhampton Assessment Tool, a Tool for Patient-reported Wellbeing in the Context of Prostate Cancer
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.
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. They can also have an empowering effect as the patient may feel that
 they are agents, and not just subjects, in their treatment pathway. In the case of advanced
 and metastatic prostate cancer (i.e. cancer which has spread from the prostate to distant
 sites), the clinical means of assessing how the patient's disease is responding to treatment
 (radiological/magnetic scans) are somewhat imperfect as they do not take into account the
 impact on the patient's life and his response and reaction. Patient-reported outcomes, such
 as WATapp, allow a way to measure the impact of clinicians' actions on patients' lives. They
 offer an assessment of how well treatments are working and this is critical in the management
 of patients with advanced or metastatic prostate cancer. Failure to recognise how the patient
 responds to treatment can lead to effective treatment being stopped inappropriately;
 progression of the disease may not always be recognised; and the patient may have unnecessary
 side effects that go unchecked. Ignoring the patient-reported outcomes, such as WATapp, can
 reduce the opportunity to use alternative treatments. WATapp has been developed as an
 objective and reproducible clinical assessment tool by using questions from these validated
 clinical study tools:

 The Functional Assessment of Cancer Therapy - Prostate; The Brief Pain Inventory; The
 Karnofsky Performance Scale

 WATapp was refined with patient and clinician input to produced the present 5-item
 questionnaire.

 This is a mixed-method study, incorporating both quantitative and qualitative elements. As
 such, it is both objective and subjective:

 1. It is subjective in that, in using the WATapp, the patient selects his response to each
 question on the basis of how he feels normally

 2. It is objective in that the tools to be used in the analysis of the quantitative data
 [i.e. statistical tests such as Mann Whitney-U, Spearman Rank Correlation etc.] are
 independent of the person using them

 3. Determining clinically the patient's disease status employs objective measures such as
 PSA, size, distribution and type of metastasis, frequency of night-time urination etc.
 as well as the clinician's professional judgment which contains both objective and
 subjective elements

 4. The researchers are not mirrors but rather prisms and hence the entire study from
 conception to analysis and report is a refraction of their experiences

 Phase 1 The main outcome of the first phase will be to refine, as necessary, both the WATapp
 and the research instruments as well as to establish proof of principle of the clinical
 utility of WATapp. This will entail a full pilot of the WATapp in New Cross Hospital,
 Wolverhampton. Patients who agree to use the WATapp to self-monitor aspects of their health
 will be invited to consent to share with the researchers their anonymised data from it as
 well as linked, anonymised clinical data. The frequency of collection of data will be at the
 discretion of the clinician. Participating patients and clinicians will be invited to take
 part in a short, semi-structured interview on their experience of using WATapp. All patient
 data will be treated anonymously, and none linked back to the patient or to their
 clinician/s. Clinicians will be asked to record any reasons given by patients who decline to
 use the WATapp. Whether a patient chooses or not to use WATapp or chooses or not to take part
 in this study will have no bearing on their clinical care.

 The clinical data sought on patients will include:

 1. Age

 2. Stage of cancer at diagnosis in terms of the primary tumour, and any presence of disease
 in lymph nodes and bones

 3. Current stage of cancer in terms of the primary tumour, and any presence of disease in
 lymph nodes and bones

 4. Level of PSA - prostate specific antigen, produced normally in the prostate but also
 produced in prostate cancer cells, testosterone and other blood results which are
 routinely measured

 5. Any other illnesses the patient may have

 6. Current and previous treatments

 Phase 2 The second phase is to invite oncologists across the West Midlands of England, many
 of whom have already expressed an interest, to join the study and to send the researchers
 anonymised, linked patient data (as in Phase 1) and that from the WATapp.
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