PREDICT: Prostate Patient Study
Research type
Research Study
Full title
Evaluation of a new tool, PREDICT: Prostate, to aid treatment decision-making for men with newly diagnosed non-metastatic prostate cancer
IRAS ID
249699
Contact name
David Thurtle
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Trust and The University of Cambridge
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The number of men diagnosed with prostate cancer is rising, in the vast majority of cases the disease has not spread elsewhere (non-metastatic). Here, treatment decisions are complex, with the risks of a cancer diagnosis balanced against potential problems associated with treatment. National guidelines advise that evidence-based decision aids should be used, yet no adequate individualised decision aid yet exists. To address the absence of such an important aid we have developed ‘PREDICT: Prostate’. This is a decision model and website which provides personalised survival estimates based on an individual’s characteristics and those of their cancer. The model allows the risk of dying from cancer to be contextualised against other risks of death and estimates the potential survival benefit from treatment.
This study seeks to assess the clinical usefulness and potential impact of PREDICT: Prostate amongst patients diagnosed with prostate cancer. We will assess the impact of the model on treatment decision-making, and on levels of concern, confidence and anxiety amongst newly diagnosed men. We will also assess how PREDICT estimates compare to patients’ perceptions about survival. We will also seek feedback about the model and its usefulness.
After selection, recruitment and informed consent, patients will be assigned to either the ‘standard of care’ (SOC) arm or to the ‘SOC + PREDICT’ arm of the study. On the date of their next planned clinical follow-up appointment, participants will be invited to attend the hospital slightly earlier for a study meeting. During this meeting, all participants will be asked to complete a questionnaire. For those in the ‘SOC and PREDICT’ arm, this questionnaire will follow a semi-structured presentation of the PREDICT: Prostate model; those in the SOC arm will complete the questionnaire only. The participant’s involvement in the study will finish after completion of the questionnaire with no further intervention or involvement required.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0254
Date of REC Opinion
25 Sep 2018
REC opinion
Further Information Favourable Opinion