Colorectal CancerCITRuS1NCT04697394
CITRuS Stage 1; Feasibility
An observational study of Colorectal Cancer, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 380 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2022to 26 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Surrey County NHS Foundation Trust
Guildford, Surrey, GU2 7XX
About this study
Official 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
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.
Read more
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.
Read the detailed description
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. 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.
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal, Cancer, PROMs, Patient Reported Outcome Measures, Electronic, Complex Intervention Protocol
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to complete the web-based electronic questionnaires online outside of the hospital setting.
Colorectal patients ability to electronically complete patient reported outcome measures
Measured: 2 years
Continuous retention of patients completing electronic data.
Sustained retention of electronic data collection from colorectal patients over a 2 year period
Measured: 2 years
Secondary outcomes (1)
Symptom cluster identification
Identification of symptom clusters in the electronic data to use for part 2 of the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start15 Mar 2022
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, The Clatterbridge Cancer Centre NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alexandra Stewart, DM, MRCP, FRCR, Principal investigator, Consultant Clinical Oncologist, Royal Surrey County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697394
- Sponsor's protocol ID
- CITRuS v3.0
- Acronym
- CITRuS1
- Status last verified
- Jun 2025
- First submitted
- 5 Jan 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04697394
- Acronym / sponsor ID
- CITRuS1 / CITRuS v3.0
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal, Cancer, PROMs, Patient Reported Outcome Measures, Electronic, Complex Intervention Protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, The Clatterbridge Cancer Centre NHS Foundation Trust
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ability to complete the web-based electronic questionnaires online outside of the hospital setting.
Time frame: 2 years
Colorectal patients ability to electronically complete patient reported outcome measures
Continuous retention of patients completing electronic data.
Time frame: 2 years
Sustained retention of electronic data collection from colorectal patients over a 2 year period
1 secondary outcome
Symptom cluster identification
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Stewart, DM, MRCP, FRCR principal investigator
Consultant Clinical Oncologist, Royal Surrey County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to complete the web-based electronic questionnaires online outside of the hospital setting. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.