Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04851639
Status:
RECRUITING
Last Update Posted:
2021-10-05
First Post:
2021-04-06
Brief Title:
The Wolverhampton Assessment Tool a Tool for Patient-reported Wellbeing in the Context of Prostate Cancer
Sponsor:
University of Wolverhampton
Organization:
University of Wolverhampton
Study Overview
Official Title:
The Wolverhampton Assessment Tool a Step Towards Remote Monitoring of Patient-reported Wellbeing in the Context of Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WATapp
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 patients 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 patients 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
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 patients 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
Detailed Description:
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 patients 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 ie cancer which has spread from the prostate to distant sites the clinical means of assessing how the patients disease is responding to treatment radiologicalmagnetic scans are somewhat imperfect as they do not take into account the impact on the patients 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 ie statistical tests such as Mann Whitney-U Spearman Rank Correlation etc are independent of the person using them
3 Determining clinically the patients disease status employs objective measures such as PSA size distribution and type of metastasis frequency of night-time urination etc as well as the clinicians 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 clinicians 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
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 ie statistical tests such as Mann Whitney-U Spearman Rank Correlation etc are independent of the person using them
3 Determining clinically the patients disease status employs objective measures such as PSA size distribution and type of metastasis frequency of night-time urination etc as well as the clinicians 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 clinicians 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None