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

Study ID: 51104
Short Title: CITRuS Stage 1; Feasibility
Trust Name: HHFT,SFT
Recruitment Site: Basingstoke and North Hampshire Hospital,Royal Hampshire County Hospital,Salisbury District Hospital
Disease Area: Colorectal cancer
Phase: N/A
Expected End Date: 23/03/2024
Postcode: RG24 9NA
SO22 5DG
SP2 8BJ
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

- Patients diagnosed with colorectal adenocarcinoma with no evidence of distant metastases - Patients due to undergo surgery or radiotherapy as a definitive treatment - > 18 years of age - The ability to complete an internet based English written questionnaire from their home or on a portable electronic device. - Patients to have read the patient information sheet and have electronically signed the informed consent

- Patient choice - < 18 years of age - History of other cancer within 5 years, excluding non-melanoma skin cancer - Evidence of metastatic disease - patients not undergoing surgery or radiotherapy as a definitive treatment - The inability to complete an internet based English written questionnaire from their home or on a portable electronic device. - Patient with history of poor compliance or current or past psychiatric conditions that would interfere with compliance to the study protocol or cause further psychological distress.

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 platform to allow colorectal cancer patients 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 platform 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.

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