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

NCT04684355 | Unknown DMC

• 1 other identifier: FJUH109047
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Quality of life degree

  Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.

  2 weeks

Secondary Outcomes (1)

• Anxiety and depression degree

  2 weeks

Study Arms (2)

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.

Other: Real-time colonoscopic optical diagnosis for colorectal neoplasm

Interventions

Real-time colonoscopic optical diagnosis for colorectal neoplasm OTHER

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.

Intervention group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Impaired mental status that could not understand the questionnaire questions.
• Patients with major psychological disorders.

Sponsors & Collaborators

• Fu Jen Catholic University: lead
• Fu Jen Catholic University Hospital: collaborator

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mental Disorders

Central Study Contacts

Chen-Ya Kuo, MD

CONTACT

+886975701515; b9402039@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, M.D.

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: December 22, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 30, 2021
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)