Colorectal NeoplasmsNCT04684355
Quality of Life of Colorectal Cancer Screenees in the Period Between Colonoscopy and Next Clinic Visit for Final Report: Does Real-time Endoscopic Optical Diagnosis Improve Their Quality of Life
A study testing Real-time colonoscopic optical diagnosis for colorectal neoplasm in people with Colorectal Neoplasms and Colonoscopy, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
Colorectal cancer screening program has been proven to reduce colorectal cancer (CRC) mortality and is cost-effective. It has been adopted by most countries in the world, and colonoscopy is regarded as the most accurate test for detecting colorectal neoplasm. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Colorectal Neoplasms, Colonoscopy, Quality of Life
- What is being tested?
- Real-time colonoscopic optical diagnosis for colorectal neoplasm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Dec 2020to 30 Dec 2021
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who preparing to received screening or surveillance colonoscopy under general anesthesia.
- Patients who preparing to received sedated colonoscopy due to other GI tract related symptoms.
Who cannot join
- Impaired mental status that could not understand the questionnaire questions.
- Patients with major psychological disorders.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital
New Taipei City, 24352
Chen-Ya Kuo, MD, 886975701515, b9402039@gmail.com
About this study
Colorectal cancer screening program has been proven to reduce colorectal cancer (CRC) mortality and is cost-effective. It has been adopted by most countries in the world, and colonoscopy is regarded as the most accurate test for detecting colorectal neoplasm. After screenees underwent colonoscopy, most endoscopists do not routinely explain the preliminary optical diagnosis to the subjects before they going home, which may cause unnecessary anxiety and may reduce the quality of life of the subjects before acquiring the final results. In recent years, endoscopic optical diagnostic technology has been validated by meta-analysis studies as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer. The real time feature of endoscopic optical diagnosis allows endoscopists to explain the preliminary results confidently to the subjects immediately after colonoscopy, which is expected to reduce the anxiety of the subjects before they acquired the final results and improve their quality of life. We designed a randomized controlled trial to validate whether real-time endoscopic optical diagnosis could decrease the anxiety burden and improve the quality of life for colorectal-cancer screenees after colonoscopy.
- Conditions
- Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
- Being tested
- Real-time colonoscopic optical diagnosis for colorectal neoplasm
- Keywords
- Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
- Medical subject headings
- Colorectal Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time colonoscopic optical diagnosis for colorectal neoplasmOther
Colonoscopic optical diagnosis by image enhanced technology has been validated as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care group | No intervention | Participants in this group received their colonoscopic and pathological diagnosis simultaneously at next clinical visit, which arranged in 1 to 2 weeks later. |
| Intervention group | Experimental | Participants in this group received their colonoscopic diagnosis right after they awake from general anesthesia, and then received pathological diagnosis at next clinical visit, which arranged in 1 to 2 weeks later. Receives: Other: Real-time colonoscopic optical diagnosis for colorectal neoplasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life degree
Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.
Measured: 2 weeks
Secondary outcomes (1)
Anxiety and depression degree
Use Hospital Anxiety and Depression Scale (HADS) Taiwanese version to measure the anxiety and depression degree between the two study arms.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start22 Dec 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Jen Catholic University Hospital
- Responsible party
- Principal investigator, Chen-Ya Kuo, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684355
- Sponsor's protocol ID
- FJUH109047
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- 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 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Colorectal Cancer Screenees in the Period Between Colonoscopy and Next Clinic Visit for Final Report: Does Real-time Endoscopic Optical Diagnosis Improve Their Quality of Life
- ClinicalTrials.gov ID
- NCT04684355
- Acronym / sponsor ID
- FJUH109047
- Conditions
- Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
- Keywords
- Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Collaborators
- Fu Jen Catholic University Hospital
- Study start
- 22 Dec 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 24 Dec 2020 (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.
Colorectal cancer screening program has been proven to reduce colorectal cancer (CRC) mortality and is cost-effective. It has been adopted by most countries in the world, and colonoscopy is regarded as the most accurate test for detecting colorectal neoplasm. After screenees underwent colonoscopy, most endoscopists do not routinely explain the preliminary optical diagnosis to the subjects before they going home, which may cause unnecessary anxiety and may reduce the quality of life of the subjects before acquiring the final results. In recent years, endoscopic optical diagnostic technology has been validated by meta-analysis studies as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer. The real time feature of endoscopic optical diagnosis allows endoscopists to explain the preliminary results confidently to the subjects immediately after colonoscopy, which is expected to reduce the anxiety of the subjects before they acquired the final results and improve their quality of life. We designed a randomized controlled trial to validate whether real-time endoscopic optical diagnosis could decrease the anxiety burden and improve the quality of life for colorectal-cancer screenees after colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care group | No intervention | –Participants in this group received their colonoscopic and pathological diagnosis simultaneously at next clinical visit, which arranged in 1 to 2 weeks later. |
| Intervention group | Experimental | Other: Real-time colonoscopic optical diagnosis for colorectal neoplasmParticipants in this group received their colonoscopic diagnosis right after they awake from general anesthesia, and then received pathological diagnosis at next clinical visit, which arranged in 1 to 2 weeks later. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who preparing to received screening or surveillance colonoscopy under general anesthesia.
- Patients who preparing to received sedated colonoscopy due to other GI tract related symptoms.
Key exclusion criteria (2 listed)
- Impaired mental status that could not understand the questionnaire questions.
- Patients with major psychological disorders.
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 |
|---|---|---|
| Real-time colonoscopic optical diagnosis for colorectal neoplasmColonoscopic optical diagnosis by image enhanced technology has been validated as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer. | Other | Intervention group |
Primary outcome
Quality of life degree
Time frame: 2 weeks
Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.
1 secondary outcome
Anxiety and depression degree
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time colonoscopic optical diagnosis for colorectal neoplasm in people with Colorectal Neoplasms and Colonoscopy, run by Fu Jen Catholic University at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Dec 2020. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Ya Kuo, MD (+886975701515, b9402039@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life degree (time frame: 2 weeks). 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 24 Dec 2020.