Psycho-oncologic Impact of Cancer Progression

• Research type

  Research Study

• Full title

  Psycho-oncological impact of progression in patients with solid tumours

• IRAS ID

  329263

• Contact name

  Nicole Tay

• Contact email

  nicole.tay@vinehealth.ai

• Sponsor organisation

  GSK Ltd

• Duration of Study in the UK

  1 years, 1 months, 23 days

• Research summary

  For new medicines or drugs to be approved by regulatory bodies, direct or indirect clinical benefit needs to be demonstrated. To date, overall survival (OS) remains the gold standard clinical outcome in oncology. However providing robust OS evidence is challenging and often takes several years to obtain​, which can potentially delay or deny critically ill patients access to life-extending novel medicines. There is increasing interest in the use of alternative clinical endpoints to study new drugs, including progression-free survival (PFS). PFS refers to time from the start of treatment until disease progression or death. More robust evidence is required to demonstrate that PFS is a patient relevant endpoint.

  This study aims to demonstrate that PFS is a relevant patient endpoint by assessing the mental distress of receiving results of disease progression on patients’ anxiety, depression, and quality of life via selected patient-reported outcome (PRO) instruments deployed through the Vinehealth mobile application.

  The study is a prospective non-interventional observational study. Patients enrolled into the study will continue to be treated as per usual standard of care (i.e. treatment and care decisions made by clinicians and healthcare professionals will follow normal clinical practice). The study aims to consecutively recruit approximately 500 patients who have been diagnosed with solid tumours to provide prospective PRO data through the Vinehealth mobile application. Patients with a first diagnosis of any malignant solid tumour type can be enrolled into this study.

  Eligible patients enrolled onto the study will be asked to complete up to 5 sets of questionnaires:
  1) Before patient's cancer scan (pre-scan)
  2) After receiving results of scan (post-scan)
  3) 2 weeks, 4 weeks and 6 weeks after completing the post-scan questionnaire

  Patient recruitment will be carried out consecutively for at least 6 months, and data collection will last for a minimum of 12 months from study commencement.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  23/PR/0735

• Date of REC Opinion

  13 Jul 2023

• REC opinion

  Favourable Opinion