CITRuS Stage 1; Feasibility
Research type
Research Study
Full title
To examine whether a Complex Intervention protocol decreases Toxicity in patients following Radiotherapy or Surgery for colorectal cancer Stage 1- feasibility of electronic data collection
IRAS ID
250672
Contact name
Alexandra Stewart
Contact email
Sponsor organisation
Royal Surrey NHS Foundation Trust
Clinicaltrials.gov Identifier
NCT04697394, ClincialTrials.Gov
Duration of Study in the UK
4 years, 0 months, 7 days
Research summary
Currently, the medical team collects information on patients’ symptoms before and after cancer treatment in response to direct questioning in outpatient clinics. It’s recognised that patient-reported symptoms often differ from doctor-documented symptoms. Over time, this leads to inaccuracies in doctors’ descriptions of the effects of cancer or its treatment to patients. Patients told us accurate description of expected symptoms is important when they are choosing which treatment to have.
This study will use an electronic database to allow colorectal cancer patients to view their treatment records and to document their symptoms. Patients will answer questions at study entry and at set intervals during treatment and follow-up. The questions are related to health and well-being. The questionnaires are patient reported outcome measures (PROMs) which have been used in paper format in trials with many patients internationally.
The information the patients give us will help doctors describe treatment effects more accurately to future patients and to identify patients who may need extra support during or after their treatment. Electronic data collection allows patterns to be identified that may not be seen by doctors until a later stage. The symptoms identified in this study will be used to develop treatments that may benefit future patients. The electronic database will be used identify the need for intervention then to deliver the recommended treatments to patients automatically when they are identified. For example, if questionnaire responses show a patient has an unplanned loss of 3% of their body weight an information sheet on increasing calorie intake and eating well with a small appetite would be emailed to them and a dietician alerted so a follow up call could be made two weeks later.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0258
Date of REC Opinion
7 Jan 2022
REC opinion
Further Information Favourable Opinion