Clinical oncology - scoring treatment effects

The aim of the outcome measures group is to develop a robust clinical tool to record and score acute and late normal-tissue effects of cancer treatments, specifically radiotherapy.

Currently there is a recognized need for an international scoring system both in clinical trials (to facilitate accurate assessment of new technologies) and in routine clinical practice. 

Background 

In 1995 the EORTC and RTOG published the late effects in normal tissues subjective, objective, management and analytic scales (LENT SOMA) in an attempt to devise an international scoring system. These scales were not ready to be adopted for widespread clinical use. To address this, the OM group established validation studies, produced user-friendly questionnaires to obtain normal tissue outcome data. In 2003 the NCI published the Common Terminology Criteria for Adverse Events (CTCAE) which incorporated the LENT SOMA items with early and late effects contained in one system. This is now seen as the preferred platform for toxicity recording in clinical trials and we have adapted the patient and healthcare professional questionnaires accordingly.

The need for measurement and assessment of late effects 

Measurement and assessment of late effects needs to be integrated into current patient management to: 

  • Provide adequate information to the patient regarding complications associated with their treatment
  • Facilitate appropriate management for these complications
  • Improve multidisciplinary support for patients suffering from normal-tissue effects
  • Permit modification of treatment regimes to account for and reduce normal-tissue effects Facilitate the development of predictive testing for normal-tissue effects

There is a need to ensure that any system developed for assessing late normal-tissue effects is appropriate for the disease site and treatment modality, and that it is feasible for use in a clinical setting. The questionnaire approach is a practical and reliable way to use the toxicity scales. Work here to validate these questionnaires has been carried out with well over 1000 patients to date at various disease sites: bladder, breast, cervix, head and neck, and prostate. These questionnaires are downloadable in pdf format. Part 1 (basic demographics) part 2 (subjective part) completed by patients in the clinic or by post and Part 3 (objective part) completed by clinician. 

The outcomes measures group 

The OM Group produced user-friendly questionnaires, which have provided a practical approach for obtaining reliable and consistent treatment effects data. The OM Group is now concentrating on refining the questionnaires, and validating them in upcoming national/international clinical trials. A major aim is to identify questions that accurately measure late radiation toxicity, and omit those questions which are non-discriminatory or superfluous.

To access the questionnaires produced by the OM group, please click here.

The OM group is led by Dr Susan Davidson. This work is supported by Jacqueline Routledge, research nurse.

 

Current work

We are seeking to simplify questionnaire scoring and improve the tool for measurement of toxicity for patient reported treatment effects to facilitate use in the clinic. We are validating a new format for a pelvic symptom questionnaire.

Project lead - Dr Susan E Davidson
Consultant and Honorary Senior Lecturer in Clinical Oncology
Radiotherapy Related Research
The Christie NHS Foundation Trust
Wilmslow Road Manchester M20 4BX

Research Nurse - Jacqueline Routledge

Department of Clinical Oncology
The Christie NHS Foundation Trust
Wilmslow Road Manchester M20 4BX

Collaborations

We are working on improving the management of bowel effects of cancer treatment to the pelvis which began with work funded by Macmillan and now have a NIHR Research for Patient Benefit grant to look at a care bundle in a pilot study to see if the bowel effects of chemo-radiotherapy of pelvic cancer can be alleviated.

RAPPER Q sub-study
Professor Alan Tennant BA, PhD
Professor of Rehabilitation Studies
University of Leeds

The clinical benefit and cost effectiveness of a gastrointestinal care bundle during pelvic chemo-radiotherapy
Professor John McLaughlin
Professor of Gastroenterology
University of Manchester

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