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Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy

Primary Purpose

Colorectal Neoplasms, Colonic Polyp, Anxiety

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Real-time endoscopic optical diagnosis

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring colonoscopy, polypectomy, image enhanced endoscopy, endoscopic optical diagnosis

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age of ≥ 40 years and < 80 years
Outpatients who prepare receiving sedated colonoscopy
Subjects who have signed informed consent form of this study
Informed consensus has been obtained that endoscopic resection should be performed if a colorectal polyp is found
Eastern Cooperative Oncology Group (ECOG) performance status scale among 0 to 2

Exclusion Criteria:

Subjects with any of the following prior history or current conditions:
(a) Contraindications to colonoscopy
(b) Major mental illnesses, e.g. major depressive disorder, schizophrenia, generalized anxiety disorder ...
(c) Inflammatory bowel disease
(d) Hereditary or non-hereditary polyposis syndrome, hereditary non-polyposis colorectal cancer
(e) Uncured colorectal cancer
(f) Active gastrointestinal bleeding
(g) Pregnancy
Subjects who do not received polypectomy during colonoscopy.

Sites / Locations

Fu Jen Catholic University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Ordinary care (OC)

Real-time notification (RTN)

Arm Description

The participants of this arm received the endoscopic optical diagnosis, histological diagnosis of the resected colon polyps and the recommended surveillance colonoscopy schedule at next scheduled clinic visit (around 1 to 2 weeks later).

The participants of this arm received the endoscopic optical diagnosis of the resected colon polyps and the recommended surveillance colonoscopy schedule right after the sedated colonoscopy. Histological diagnosis will be informed at next scheduled clinic visit (around 1 to 2 weeks later).

Outcomes

Primary Outcome Measures

Proportion of definite anxiety cases

The level of anxiety of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results. The anxiety score of this questionnaire ranging from 0 to 21. Scored 0 to 7 defined as normal case, scored 8 to 10 defined as doubtful case, and scored 11 to 21 defined as definite case. The proportion of definite anxiety cases of the two study arms will be compared.

Proportion of definite depression cases

The level of depression of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results. The depression score of this questionnaire ranging from 0 to 21. Scored 0 to 7 defined as normal case, scored 8 to 10 defined as doubtful case, and scored 11 to 21 defined as definite case. The proportion of definite depression cases of the two study arms will be compared.

Secondary Outcome Measures

Anxiety score

The level of anxiety of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results and compared the difference between the two study arms. The anxiety score of this questionnaire ranging from 0 to 21. Higher score means higher anxiety level.

Depression score

The level of depression of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results and compared the difference between the two study arms. The depression score of this questionnaire ranging from 0 to 21. Higher score means higher depression level.

Full Information

NCT ID

NCT05517343

First Posted

August 19, 2022

Last Updated

August 25, 2022

Sponsor

Fu Jen Catholic University

1. Study Identification

Unique Protocol Identification Number

NCT05517343

Brief Title

Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy

Official Title

Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy: a Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 20, 2022 (Anticipated)

Primary Completion Date

August 31, 2025 (Anticipated)

Study Completion Date

August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fu Jen Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The accuracy of endoscopic optical diagnosis for colorectal polyps has been approaching histological diagnosis after implementation of image enhancement endoscopic technologies. The real-time notification of possible nature of resected polyp after colonoscopy is expected to reduce the anxiety and depression level of the patients before the availability of histological diagnosis and improve their quality of life. We designed and conducted a randomized control trial to confirm this hypothesis.

Detailed Description

This is a single center, open-label, prospective and parallel randomized controlled trial. This study planning to recruit outpatients from the age of 40 to 79 who are scheduled to undergo sedated colonoscopy. Once eligible subjects were diagnosed of colorectal polyps during colonoscopy and received polypectomy, they will be randomized into "ordinary care group (explained at next scheduled clinic)" and "real-time notification group (explained immediately after colonoscopy)". The level of anxiety, depression of the two groups will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results and compared the difference between the two groups.This study is expected to determine the impact of real-time notification of colonoscopic optical diagnosis on patients' anxiety and depression after polypectomy, and provide evidence to improve post-polypectomy care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Colonic Polyp, Anxiety, Depression, Colonoscopy

Keywords

colonoscopy, polypectomy, image enhanced endoscopy, endoscopic optical diagnosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a single center, open-label, prospective and parallel randomized controlled trial. This study planning to recruit outpatients from the age of 40 to 79 who are scheduled to undergo sedated colonoscopy and received polypectomy during the procedure. Participants will be randomized into "ordinary care group (explained at next scheduled clinic)" and "real-time notification group (explained immediately after colonoscopy)" in 1:1 ratio. Randomization will be based on a computer-generalized randomization list and stratified by gender and baseline anxiety degree of the participants. The level of anxiety, depression of the two groups will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale right before the next scheduled clinic for histological results and compared the difference between the two groups.

Masking

None (Open Label)

Masking Description

The participants, care providers, investigators and outcome assessors are not blinded to the assigned study arm.

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ordinary care (OC)

Arm Type

No Intervention

Arm Description

Arm Title

Real-time notification (RTN)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Real-time endoscopic optical diagnosis

Intervention Description

The participants assigned to real-time notification group will received the endoscopic diagnosis of the resected colorectal polyps and recommended surveillance colonoscopy schedule right after the sedated colonoscopy.

Primary Outcome Measure Information:

Title

Proportion of definite anxiety cases

Description

Time Frame

This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..

Title

Proportion of definite depression cases

Description

Time Frame

This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..

Secondary Outcome Measure Information:

Title

Anxiety score

Description

The level of anxiety of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results and compared the difference between the two study arms. The anxiety score of this questionnaire ranging from 0 to 21. Higher score means higher anxiety level.

Time Frame

This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..

Title

Depression score

Description

The level of depression of the two study arms will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results and compared the difference between the two study arms. The depression score of this questionnaire ranging from 0 to 21. Higher score means higher depression level.

Time Frame

This outcome will be assessed right before the next scheduled clinic for histological results (around 1 to 2 weeks after polypectomy)..

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age of ≥ 40 years and < 80 years Outpatients who prepare receiving sedated colonoscopy Subjects who have signed informed consent form of this study Informed consensus has been obtained that endoscopic resection should be performed if a colorectal polyp is found Eastern Cooperative Oncology Group (ECOG) performance status scale among 0 to 2 Exclusion Criteria: Subjects with any of the following prior history or current conditions: (a) Contraindications to colonoscopy (b) Major mental illnesses, e.g. major depressive disorder, schizophrenia, generalized anxiety disorder ... (c) Inflammatory bowel disease (d) Hereditary or non-hereditary polyposis syndrome, hereditary non-polyposis colorectal cancer (e) Uncured colorectal cancer (f) Active gastrointestinal bleeding (g) Pregnancy Subjects who do not received polypectomy during colonoscopy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen-Ya Kuo, bachelor

Phone

+886975701515

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

b9402039@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy

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