Improving assessment & recording of pelvic cancer treatment effects
Research type
Research Study
Full title
Optimising Individual Treatment Regimes and Patient Outcomes through the Use of Patient Reported Toxicity Assessments in Patients treated with Pelvic Radiotherapy
IRAS ID
126216
Contact name
Alexandra Gilbert
Contact email
Research summary
The study aim is to improve the monitoring and support of patient’s side effects during and after treatment for pelvic (chemo)radiotherapy and help predict long-term effects of treatment. Research has found both patients and clinicians benefit from patients self-reporting on side effects. The process has been found to improve symptom and functional monitoring, as well as communication and clinical decision-making.
Phase 1: Aims to select a survey from validated instruments for patients who are having treatment or have had treatment with radical (curative) (chemo)radiotherapy for cervical, endometrial, rectal or anal cancer.
The survey will be selected after expert interviews with patients and health professionals. The final questionnaire(s) will be piloted. The electronic survey asks questions about patients’ symptoms/side effects related to treatment. The aim is for patients to complete this survey at home via the Internet or on touch screen computers in clinic before their consultations. The self-reported information will be available to clinicians via patient’s electronic records.
Phase 2: In order to capture long-term toxicity within the timescale of a PhD (3 years) a cross-sectional study with a single electronic toxicity assessment has be designed. Patients in the cross-sectional study will have completed treatment in the last 1-5 years.
Phase 3: A prospective study has been designed to understand the trajectory of side effects during and after treatment. We aim to collect self-reported toxicity information before treatment (to establish baseline symptoms), during radiotherapy treatment and at optimal times during a one-year follow-up period.
Phase 2&3: Self-reported toxicity data will be compared in detail to the radiotherapy treatment plan as well as other patient-related factors (e.g. co-morbidities, smoking status) and treatment-related factors (e.g. chemotherapy, surgery).
The aim is to examine associations between patient-reported toxicity, patient clinical data and radiotherapy treatment to explore predictive models linking radiotherapy treatment to toxicity severity.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0156
Date of REC Opinion
25 Jun 2013
REC opinion
Further Information Favourable Opinion