Linking CHHiP data with GP records of patients

• Research type

  Research Study

• Full title

  Linking CHHiP data with GP records of patients: pilot study. The effect of cardiovascular and diabetes medications on reducing complications from radiotherapy and improving health-related outcomes of prostate cancer patients

• IRAS ID

  190295

• Contact name

  Agnieszka Lemanska

• Contact email

  a.lemanska@surrey.ac.uk

• Sponsor organisation

  University of Surrey

• Clinicaltrials.gov Identifier

  AC0517, Project code within the Universit of Surrey

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  Patients that receive cancer treatment often have one or more co-morbid conditions that are treated pharmacologically. The aim of this study is to explore the effect of cardiovascular and diabetes medications that are taken during radiotherapy to treat those co-existing conditions on the incidence and severity of toxicity of radiotherapy treatment.

  This project is designed to add to the new emerging evidence that medication such as statins and ACE-inhibitors may be associated with reduced toxicity and improved treatment outcomes.

  We will conduct our research by linking the two types of data. 1) The severity of radiation toxicity and symptoms recorded as treatment side-effects using patient reported outcome measures (PROMs) and clinicians reported toxicity from CHHiP trial, and 2) The medical history of patients from GP records.

  CHHiP data used in this study will include PROMs data collected with the Expanded Prostate Cancer Index Composite (EPIC) tool and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Clinician reported toxicity data related to radiotherapy toxicity collected with the Radiation Therapy Oncology Group (RTOG) and Late Effects Normal Tissue Toxicity; subjective, objective, management, and analytic (LENT/SOMA) tools will also be used. In particular we are interested in urinary, rectal and sexual function symptoms and health outcomes. Therefore symptoms such as urinary frequency, urinary bother, rectal bleeding, rectal bother and erectile dysfunction will be extracted.

  The information from GP records that will be extracted for CHHiP patients will include co-morbidities (cardiovascular and diabetes) and medications history taken for those conditions before, during and after radiotherapy.

  We will perform preliminary data analysis on the effect of concomitant medications on the toxicity. This is an innovative approach, as previous research has only been able to identify factors related to increased toxicity. However, methods of reducing side-effects of radiotherapy by pharmacologically protecting normal tissue against damage from radiation have not yet been explored.

  The aims of this study are outlined as follows:
  • To perform systemic literature review and explore the evidence base regarding the effect of concomitant medications and side-effects of radiotherapy
  • To obtain information on urinary, rectal and sexual symptoms and treatment toxicity together with encrypted (irreversibly hashed) NHS numbers of CHHiP patients
  • Using encrypted NHS numbers to access GP medical history (medications and co-morbidities) for patients in the CHHiP study
  • To link medications to radiotherapy-related toxicity and to perform preliminary data analysis of the effect of medications on symptoms and treatment side-effects

• REC name

  West of Scotland REC 1

• REC reference

  16/WS/0076

• Date of REC Opinion

  7 Apr 2016

• REC opinion

  Favourable Opinion