JN1017C - mCRPC - UK

  • Research type

    Research Study

  • Full title

    Qualitative Study to Understand the Emotional Response to a Metastatic Diagnosis in Castration-Resistant Prostate Cancer (CRPC)

  • IRAS ID

    222220

  • Contact name

    Jason Randall

  • Contact email

    Jason.randall@clinoutsolutions.com

  • Sponsor organisation

    Clinical Outcomes Solutions

  • Clinicaltrials.gov Identifier

    JN1017C , Emotional impact of mCRPC

  • Duration of Study in the UK

    0 years, 1 months, 30 days

  • Research summary

    The overall aim of this project is to assess the emotional response of men with Castration-Resistant Prostate Cancer (CRPC), post-metastatic diagnosis. This research is being undertaken to understand the emotional burden of metastatic Castration-Resistant Prostate Cancer (mCRPC) on patients to support the development of a new drug.

    This study will involve in-depth, qualitative, one-to-one telephone Interviews with men (n = 8) with a recent diagnosis of metastatic Castration-Resistant Prostate Cancer (mCRPC). In addition, for a subsample of patients (n=4), interviews will also be conducted with the patient’s primary support person (a friend or family member who has provided support to the patient emotionally and/or in everyday tasks/care). Interviews will be conducted to the point of saturation (when there are no new concepts emerging from subsequent interviews), and so additional interviews may potentially be conducted until this is achieved. No intervention or treatment will be administered as part of this study.

    As well as this UK study, this research is also being undertaken in the US, France and Germany, and is currently under ethical review in these countries.

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    17/EM/0139

  • Date of REC Opinion

    16 May 2017

  • REC opinion

    Further Information Favourable Opinion