CITRuS Stage 1; Feasibility

NCT04697394 | Completed

• 1 other identifier: CITRuS v3.0
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

Bowel cancer is the third most common cancer occurring in the UK. Treatment usually involves surgery, often with chemotherapy or radiotherapy. In some cases radiotherapy can be used instead of surgery, especially if surgery may cause a higher risk of symptoms or a colostomy bag. Currently, the medical team collects information on patients' symptoms before and after treatment by direct questions in a clinic setting. It's recognised that patient-reported symptoms often differ from doctor-documented symptoms. This leads to inaccuracies in doctors' descriptions of the effects of cancer or treatment to patients. Patients told us an accurate description of expected symptoms is important when they are choosing their treatment. Patient-Reported outcomes measures (PROMs) may help us identify what affects the QoL after treatment and develop ways to improve it. The primary aim of the trial is to evaluate whether patients find it acceptable to use electronic data collection to assess their symptoms. Many bowel cancer patients are elderly and they may find electronic data system collection more challenging. The secondary aim is to identify which symptoms impact QoL. This will lead to the development of treatments to manage these symptoms which will be assessed in CITRuS2. All patients diagnosed with bowel cancer are entered into the colorectal database to determine the effectiveness of cancer treatments and outcomes. Participants will electronically answer questionnaires at study entry and during follow up. The questions are related to health and well-being with a holistic approach. The questions will take approximately 45 minutes to answer the first time and then 15 minutes thereafter. Following consent, participants gain access to their clinical details on the database. Then they can use a computer, laptop, tablet or smart phone to access a webpage and answer questions at monthly intervals over a 2 year period. Email reminders will be sent to prompt log on. This may help discover how bowel cancer and its treatment affect patients and their lives. This may help doctors describe the effects of treatment more accurately to future patients. It may also help doctors identify which patients need extra help or support through their treatment. Electronic data may allow patterns to be identified that may not be seen by doctors until a later stage. This may enable earlier treatment resulting in less time with symptoms, which could be physically and economically beneficial.

Conditions

Colorectal Cancer

Keywords

Colorectal; Cancer; PROMs; Patient Reported Outcome Measures; Electronic; Complex Intervention Protocol

Outcome Measures

Primary Outcomes (2)

• Ability to complete the web-based electronic questionnaires online outside of the hospital setting.

  Colorectal patients ability to electronically complete patient reported outcome measures

  2 years

• Continuous retention of patients completing electronic data.

  Sustained retention of electronic data collection from colorectal patients over a 2 year period

  2 years

Secondary Outcomes (1)

• Symptom cluster identification

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 18 years of age, any sex and any ethnicity who have been diagnosed with a colorectal adenocarcinoma with no evidence of distant metastases and will be receiving radiotherapy and/or surgical treatment.

You may qualify if:

• Patients diagnosed with colorectal cancer from the 5 participating centres (Guilford, Clatterbridge, Nottingham, Queens Hospital and Hull)
• No distant metastases
• Patients due to undergo surgery or radiotherapy as a definitive treatment
• ≥ 18 years of age. No maximum age.
• The ability to complete an internet based English written questionnaire either from their home or on a portable electronic device
• Patients to have read the patient information sheet and have electronically signed the informed consent
• Follow-up in clinic possible

You may not qualify if:

• Patient choice
• \< 18 years of age
• Evidence of metastatic disease
• History of other cancer less than five years ago, 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 at 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.

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• The Clatterbridge Cancer Centre NHS Foundation Trust: collaborator

Study Sites (1)

Royal Surrey County NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alexandra Stewart, DM, MRCP, FRCR

  Consultant Clinical Oncologist, Royal Surrey County Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: March 15, 2022
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

GB (1)