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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety

Intervention / Treatment
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* Other: Real-time colonoscopic optical diagnosis for colorectal neoplasm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Impaired mental status that could not understand the questionnaire questions. Patients with major psychological disorders.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard-of-care group<br>Participants in this group received their colonoscopic and pathological diagnosis simultaneously at next clinical visit, which arranged in 1 to 2 weeks later. | |
| Experimental: Intervention group<br>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. | Other: Real-time colonoscopic optical diagnosis for colorectal neoplasm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life degree | Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety