跳至主要内容
临床试验/NCT04851639
NCT04851639招募中不适用

The Wolverhampton Assessment Tool, a Step Towards Remote Monitoring of Patient-reported Wellbeing in the Context of Prostate Cancer

University of Wolverhampton2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
WATapp as a proxy for patients' clinical status

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

WATapp as a proxy for patients' clinical status

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr David Matheson

Principal Investigator

University of Wolverhampton

研究点 (2)

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