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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684355
• Other study ID #: FJUH109047
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2020
• Source: Fu Jen Catholic University
• Contact: Chen-Ya Kuo, MD
• Phone: +886975701515
• Email: b9402039[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Colonoscopy
• Colorectal Neoplasms
• Mass Screening
• Quality of Life

Intervention

Other:
• Real-time colonoscopic optical diagnosis for colorectal neoplasm
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.

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Fu Jen Catholic University	Fu Jen Catholic University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life degree	Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.	2 weeks
Secondary	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