Colorectal CancerPREPCOLONNCT06314022
A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP)
A study testing Mobile application for colonoscopy preparation instructions in people with Colorectal Cancer and Premalignant Colon Lesions, run by Hospital del Rio Hortega at 2 sites in Spain.
Trial summary
Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer, Premalignant Colon Lesions
- What is being tested?
- Mobile application for colonoscopy preparation instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 2 sitesSpain
- Study dates
- 2 May 2024to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Subjects between 50-69 years old from the CRC screening program with FIT (>100ng/ml).
- Informed consent granted in writing
Who cannot join
- Refusal to give informed consent.
- Those who do not have a smartphone with a minimum version of the operating system (Android 4.4 or iOS 14, which cover more than 99% of the terminals in use)
- Symptomatic patients
- Subjects at elevated risk of CRC due to family history or inherited polyposis diseases or inflammatory bowel disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Rio Hortega
Valladolid, Valladolid, 47012
Henar Nuñez
- Recruiting
Hospital Universitario Rio Hortega
Valladolid, Valladolid, 47012
Mª Henar Núñez Rodríguez, MD PhD, 34 983 4202400 ext. 84 433, henarnrod@yahoo.es
Mª Henar Nuñez Rodriguez, MD PhD, henarnrod@yahoo.es
About this study
Official title: Design of a Mobile Application to Improve the Quality of Colonoscopy and Its Implementation in Colorectal Cancer Screening Program: a Randomized Multicenter Study (PrepColon APP Study)
Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake.
Read the detailed description
STUDY DESIGN AND METHODS
Study Design:
Phase 1: Design of the mobile application (APP): The APP will be designed in a participatory manner by the research team of the project, formed by doctors, nurses, statisticians and telecommunications engineers. The application should be usable with both Android and iOS devices, so we will use the Flutter framework to build apps for different platforms with a single code base.
When arranging a colonoscopy, the patient will install the APP on their mobile phone and indicate the date and time of the test. The APP will be responsible for supporting the preparation of the colon cleansing, for which, in addition to being able to visualize the corresponding information, it will make use of notifications to show diet reminders and laxative intakes.
More specifically, these could be some notifications:
- (3 days before the appointment) - Notification of start of preparation with a low fibre diet
- (24 hours before the appointment) - Notification of .laxative intake..
The APP will also consider the comorbidities and drugs of each participant. It can be adapted to the different types of laxative (4, 2 or 1 litre) and notify the need to discontinue anticoagulant and/or antiplatelet treatments by contacting with the primary care physician. Additionally, the application may ask short questions to control the laxative intake instruction. The user must confirm the appointment 48 hours in advance. The design of the APP aims to be intuitive and easy to use by the target population (50-69 years), allowing to adapt the font size and zoom in on the images to facilitate the visualization of the information.
The APP will be multilingual for English and Spanish, and others may be incorporated if deemed necessary. An agile and iterative methodology of software development will be followed as SCRUM in the realization of the APP. Thus, sprints of about 3 weeks will be planned with delivery of functional software that will progressively incorporate the different functionalities planned for the APP.
Phase 2: Re-evaluation of the APP after the inclusion of 30 patients, the APP will be re-evaluated through a usability questionnaire and adjustments and changes will be made if necessary
Phase 3: Prospective, multicentre and randomized study in asymptomatic patients between 50 and 69 years who attend screening colonoscopy after a positive FIT >100 ng / ml)
The study will be carried out in the Digestive Service of 3 hospitals in Castilla y León: Virgen de la Concha Hospital in Zamora, Medina del Campo Hospital and Río Hortega University Hospital in Valladolid. Participants will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: the investigators will give the instructions in writing and will also indicate how to install the APP to the participants.
- Conditions
- Colorectal Cancer, Premalignant Colon Lesions
- Being tested
- Mobile application for colonoscopy preparation instructions
- Keywords
- quality colonoscopy, colorrectal cancer screening, mobile application
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application for colonoscopy preparation instructionsOther
The APP will also consider the comorbidities and drugs of each patient. It can be adapted to the different types of laxative (4, 2 or 1 litre) and notify the need to discontinue anticoagulant and/or antiplatelet treatments by contacting with the primary care physician. Additionally, the application may ask short questions to the patient to control the laxative intake instruction. The user must confirm the appointment 48 hours in advance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | which receives the standard information given in writing, |
| APP group | Active comparator | Group which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative. Receives: Other: Mobile application for colonoscopy preparation instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with the diet and intake of laxatives with the use of a mobile application
Questionnaire about ASSESSMENT OF DIET COMPLIANCE (number of portions 0->2, higher points means worse outcome):
Have you followed the diet without fiber the 3 days prior to preparation: YES/ NO
- Have you eaten fruits, vegetables and legumes? number of portions 0 1 2 >2
- Have you eaten whole grain products? number of portions 0 1 2 >2
- Have you eaten meats and sausages? number of portions 0 1 2 >2
- Have you eaten blue fish? number of portions 0 1 2 >2
- Have you eaten nuts? number of portions 0 1 2 >2
- Have you eaten anything solid in the last 24 hours? yes/ no
Measured: at the moment of the procedure
Evaluate the quality of colon cleansing with mobile application as an experimental factor
The endoscopy will assess colon cleansing according to the Boston Bowel Scale (BBPS) uses a 4-point rating system (0-3) applied to each of the 3 segments of the colon (right, transverse, left) to assess colon cleanliness during the withdrawal phase of colonoscopy, after all cleaning maneuvers have been performed. (0 worse outcome and 3 best outcome)
Measured: at the moment of the procedure
Assessment of the usability of the APP
A questionare: System Usability scale (SUS), ten question about usability with Five responses ranging from Strongly Agree to Strongly Disagree
Measured: at the moment of the procedure
Compliance with the laxative intake with the use of the mobile application
Questionnaire to EVALUATE COMPLIANCE WITH TAKING THE LAXATIVE: questions like at • --Type of laxative: (name):
- Colonoscopy appointment (time) Morning / Afternoon
- Start of taking the laxative: time:
- End of taking the laxative (How many hours ago did you finish taking the laxative before the appointment?
- Have you taken all of the laxative?
- How much liquid have you drunk?
- How many shots have you done it in? How much liquid does each drink?
Measured: At the moment of the procedure
Secondary outcomes (4)
Assessment of the difficulty of the preparation instructions
quesionnaire: EVALUATION OF THE COMPRESSION OF THE INSTRUCTIONS GIVEN: scale from 0 to 10 (0:worse outcomes and 10: best outcomes)
Measured: at the moment of the procedure
Evaluate colonoscopy quality indicators:
Adenoma detection rate (ADR) is the percentage of patients with at least one histologically proven adenoma or carcinoma
Measured: at the moment of the procedure and after one month with the histological results
Evaluate attendance at the scheduled colonoscopy appointment
Attendance or not to colonoscopy appointment
Measured: at the moment of the colonoscopy
Evaluate colonoscopy quality indicators
Cecal intubation rate is the percentage of patients with completed colonoscopy
Measured: at the moment of the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start2 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: they will be given the instructions in writing and will also be indicated how to install the APP.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Henar Núñez Rodriguez, MD PhD, Hospital del Rio Hortega
- Investigators
- Henar Nuñez Rodriguez, MDPhD, Principal investigator, Hospital Universitario Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314022
- Sponsor's protocol ID
- 22-PI113
- Acronym
- PREPCOLON
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Mobile Application to Improve the Quality of Colonoscopy and Its Implementation in Colorectal Cancer Screening Program: a Randomized Multicenter Study (PrepColon APP Study)
- ClinicalTrials.gov ID
- NCT06314022
- Acronym / sponsor ID
- PREPCOLON / 22-PI113
- Conditions
- Colorectal Cancer, Premalignant Colon Lesions
- Keywords
- quality colonoscopy, colorrectal cancer screening, mobile application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake.
Detailed description
STUDY DESIGN AND METHODS
Study Design:
Phase 1: Design of the mobile application (APP): The APP will be designed in a participatory manner by the research team of the project, formed by doctors, nurses, statisticians and telecommunications engineers. The application should be usable with both Android and iOS devices, so we will use the Flutter framework to build apps for different platforms with a single code base.
When arranging a colonoscopy, the patient will install the APP on their mobile phone and indicate the date and time of the test. The APP will be responsible for supporting the preparation of the colon cleansing, for which, in addition to being able to visualize the corresponding information, it will make use of notifications to show diet reminders and laxative intakes.
More specifically, these could be some notifications:
- (3 days before the appointment) - Notification of start of preparation with a low fibre diet
- (24 hours before the appointment) - Notification of .laxative intake..
The APP will also consider the comorbidities and drugs of each participant. It can be adapted to the different types of laxative (4, 2 or 1 litre) and notify the need to discontinue anticoagulant and/or antiplatelet treatments by contacting with the primary care physician. Additionally, the application may ask short questions to control the laxative intake instruction. The user must confirm the appointment 48 hours in advance. The design of the APP aims to be intuitive and easy to use by the target population (50-69 years), allowing to adapt the font size and zoom in on the images to facilitate the visualization of the information.
The APP will be multilingual for English and Spanish, and others may be incorporated if deemed necessary. An agile and iterative methodology of software development will be followed as SCRUM in the realization of the APP. Thus, sprints of about 3 weeks will be planned with delivery of functional software that will progressively incorporate the different functionalities planned for the APP.
Phase 2: Re-evaluation of the APP after the inclusion of 30 patients, the APP will be re-evaluated through a usability questionnaire and adjustments and changes will be made if necessary
Phase 3: Prospective, multicentre and randomized study in asymptomatic patients between 50 and 69 years who attend screening colonoscopy after a positive FIT >100 ng / ml)
The study will be carried out in the Digestive Service of 3 hospitals in Castilla y León: Virgen de la Concha Hospital in Zamora, Medina del Campo Hospital and Río Hortega University Hospital in Valladolid. Participants will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: the investigators will give the instructions in writing and will also indicate how to install the APP to the participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Each subject will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: they will be given the instructions in writing and will also be indicated how to install the APP.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –which receives the standard information given in writing, |
| APP group | Active comparator | Other: Mobile application for colonoscopy preparation instructionsGroup which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -Subjects between 50-69 years old from the CRC screening program with FIT (>100ng/ml).
- Informed consent granted in writing
Key exclusion criteria (4 listed)
- Refusal to give informed consent.
- Those who do not have a smartphone with a minimum version of the operating system (Android 4.4 or iOS 14, which cover more than 99% of the terminals in use)
- Symptomatic patients
- Subjects at elevated risk of CRC due to family history or inherited polyposis diseases or inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application for colonoscopy preparation instructionsThe APP will also consider the comorbidities and drugs of each patient. It can be adapted to the different types of laxative (4, 2 or 1 litre) and notify the need to discontinue anticoagulant and/or antiplatelet treatments by contacting with the primary care physician. Additionally, the application may ask short questions to the patient to control the laxative intake instruction. The user must confirm the appointment 48 hours in advance. | Other | APP group |
Primary outcome
Compliance with the diet and intake of laxatives with the use of a mobile application
Time frame: at the moment of the procedure
Questionnaire about ASSESSMENT OF DIET COMPLIANCE (number of portions 0->2, higher points means worse outcome): Have you followed the diet without fiber the 3 days prior to preparation: YES/ NO * Have you eaten fruits, vegetables and legumes? number of portions 0 1 2 >2 * Have you eaten whole grain products? number of portions 0 1 2 >2 * Have you eaten meats and sausages? number of portions 0 1 2 >2 * Have you eaten blue fish? number of portions 0 1 2 >2 * Have you eaten nuts? number of portions 0 1 2 >2 * Have you eaten anything solid in the last 24 hours? yes/ no
Evaluate the quality of colon cleansing with mobile application as an experimental factor
Time frame: at the moment of the procedure
The endoscopy will assess colon cleansing according to the Boston Bowel Scale (BBPS) uses a 4-point rating system (0-3) applied to each of the 3 segments of the colon (right, transverse, left) to assess colon cleanliness during the withdrawal phase of colonoscopy, after all cleaning maneuvers have been performed. (0 worse outcome and 3 best outcome)
Assessment of the usability of the APP
Time frame: at the moment of the procedure
A questionare: System Usability scale (SUS), ten question about usability with Five responses ranging from Strongly Agree to Strongly Disagree
Compliance with the laxative intake with the use of the mobile application
Time frame: At the moment of the procedure
Questionnaire to EVALUATE COMPLIANCE WITH TAKING THE LAXATIVE: questions like at • --Type of laxative: (name): * Colonoscopy appointment (time) Morning / Afternoon * Start of taking the laxative: time: * End of taking the laxative (How many hours ago did you finish taking the laxative before the appointment? * Have you taken all of the laxative? * How much liquid have you drunk? * How many shots have you done it in? How much liquid does each drink?
4 secondary outcomes
Assessment of the difficulty of the preparation instructions
Time frame: at the moment of the procedure
Evaluate colonoscopy quality indicators:
Time frame: at the moment of the procedure and after one month with the histological results
Evaluate attendance at the scheduled colonoscopy appointment
Time frame: at the moment of the colonoscopy
Evaluate colonoscopy quality indicators
Time frame: at the moment of the colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Henar Nuñez Rodriguez, MDPhD principal investigator
Hospital Universitario Rio Hortega
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application for colonoscopy preparation instructions in people with Colorectal Cancer and Premalignant Colon Lesions, run by Hospital del Rio Hortega at 2 sites in Spain.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henar Nuñez Rodriguez, MDPhD (34 983 420400, henarnrod@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with the diet and intake of laxatives with the use of a mobile application (time frame: at the moment of the procedure). The study lists 4 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 4 Jun 2026.