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
Primary Purpose
Colorectal Neoplasms, Colonoscopy, Quality of Life
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Real-time colonoscopic optical diagnosis for colorectal neoplasm
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
Eligibility Criteria
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.
Sites / Locations
- Fu Jen Catholic University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard-of-care group
Intervention group
Arm Description
Participants in this group received their colonoscopic and pathological diagnosis simultaneously at next clinical visit, which arranged in 1 to 2 weeks later.
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.
Outcomes
Primary Outcome Measures
Quality of life degree
Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04684355
First Posted
December 21, 2020
Last Updated
December 23, 2020
Sponsor
Fu Jen Catholic University
Collaborators
Fu Jen Catholic University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04684355
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 22, 2020 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Jen Catholic University
Collaborators
Fu Jen Catholic University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
Keywords
Colorectal Neoplasms, Colonoscopy, Quality of Life, Mass Screening, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard-of-care group
Arm Type
No Intervention
Arm Description
Participants in this group received their colonoscopic and pathological diagnosis simultaneously at next clinical visit, which arranged in 1 to 2 weeks later.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Real-time colonoscopic optical diagnosis for colorectal neoplasm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life degree
Description
Use WHOQOL-BREF Taiwanese version to measure the quality of life between the two study arms.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Anxiety and depression degree
Description
Use Hospital Anxiety and Depression Scale (HADS) Taiwanese version to measure the anxiety and depression degree between the two study arms.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-Ya Kuo, MD
Phone
+886975701515
Email
b9402039@gmail.com
Facility Information:
Facility Name
Fu Jen Catholic University Hospital
City
New Taipei City
ZIP/Postal Code
24352
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen-Ya Kuo, MD
Phone
886975701515
Email
b9402039@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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