optimal

Project Title: OPTIMAL – Optimising Individual Treatment Regimes and Patient Outcomes through the Use of Patient-Reported Toxicity Assessments in Patients treated with Pelvic Radiotherapy

Project Start Date: Jan 2013

Anticipated End Date: December 2015

Background

Improvements in cancer survival have led to an increasing number of patients with significant long side effects/toxicity. The multiple treatment modalities used to treat pelvic cancer make monitoring toxicity challenging and a systematic method of documenting acute and late side effects has yet to be used in routine clinical care.

Aims

This project aims to establish the feasibility of introducing an electronic system for patients to self-report side effects and symptoms during and after completing radiotherapy treatment for pelvic cancer. This approach will identify patients suffering serious toxicity; allowing focused management of their problems. The toxicity information will be linked with individual patient and treatment-related information, in order to establish the relationship with acute and late toxicity to better individualise radiotherapy treatments in the future and reduce side effects.

Objectives

  1. To select a questionnaire for patients to self-report acute and late toxicity during and after pelvic radiotherapy.
  2. Use a cross-sectional study to administer the toxicity instrument to describe frequency/severity of late toxicity up to 5 years post treatment and validate the instrument.
  3. Prospectively measure acute and long term toxicities over a one year period with pelvic radiotherapy using the toxicity instrument to establish feasibility, trajectory, frequency and severity.
  4. To examine associations between patient-reported toxicity, patient clinical data and radiotherapy treatment to explore predictive models linking radiotherapy treatment to toxicity severity.

Methods
Phase 1:

  • Systematic and literature review of existing validated toxicity instruments
  • Semi-structured interviews with 8 health professionals and cognitive interviews with 16-24 patients. The aim of the interviews is to establish the quality, usefulness and relevance of existing toxicity questionnaires.
  • Pilot survey of the selected questionnaire(s) with 20 patients.
    • Patients will either be currently undergoing or have had treatment with pelvic (chemo) radiotherapy for anal, rectal, cervical or uterine cancer.

Phase 2:
Cross-sectional study of 373 patients treated in the past 1-5 years with radical (curative) or adjuvant (chemo) radiotherapy for anal, rectal, cervical or uterine cancer. Patients will complete a single electronic toxicity questionnaire and these responses will be analysed in relation to patient related and treatment related information.

Phase 3:
Prospective longitudinal study of 130 patients. All patients will undergo radical and adjuvant (chemo) radiotherapy for anal, rectal, cervical and uterine cancer. Patient will complete an electronic baseline symptom questionnaire and then complete the electronic toxicity questionnaires at multiple time points during and after their treatment. Their responses will be analysed in relation to patient related and treatment related information.

Outcomes

  • Establish the feasibility of introducing an electronic system for patients to self-report side effects and symptoms during and after completing radiotherapy treatment for pelvic cancer.
  • By linking toxicity information to individual patient and treatment-related information we hope to better understand the relationship with acute and late toxicity to better individualise radiotherapy treatments in the future and reduce side effects.

The Research Team
Chief Investigator: Dr Alexandra Gilbert (NIHR Doctoral Research Fellow and Clinical Oncology Specialist Trainee)

Supervisors

  1. Professor Galina Velikova (Professor of Psychosocial and Medical Oncology)
  2. Professor David Sebag-Montefiore (Professor of Clinical Oncology and Health Research)
  3. Dr Susan Davidson (Consultant Clinical Oncologist and Hon. Senior Lecturer)

Advisors

  1. Medical Physics – John Lilley (St. James’ University Hospital)
  2. Statistician – Helen Thygesen (University of Leeds)
  3. David Wilkinson – patient representative

The study is funded by the NHS National Institute of Health Research (NIHR)
Grant Reference Number DRF-2012-05-201.