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NCT04697394Completed

CITRuS Stage 1; Feasibility

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

Source: ClinicalTrials.gov · Last updated 25 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
380 (actual)
First submitted
5 Jan 2021
Start date
15 Mar 2022
Primary completion date
26 Jul 2024
Lead sponsor
Royal Surrey County Hospital NHS Foundation Trust
NCT number
NCT04697394

What you commit to

  • Study type: Observational
  • Participants enrolled: 380
  • From 15 Mar 2022 to the primary completion date, 26 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • 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.

Age

  • \< 18 years of age

Other

  • Patient choice
  • The inability to complete an internet based English written questionnaire at home or on a portable electronic device

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Surrey County NHS Foundation Trust
Coordinator of this site? Confirm its status
GuildfordUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.