NCT03209739

Brief Summary

It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 2014. CRC is one of the most preventable cancers because its development in general follows an adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC. Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk asymptomatic individuals starting at age 50. Modalities such as guaiac-based fecal occult blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy (FS), and colonoscopy are among the acceptable options for CRC screening. While early detection and removal of colorectal adenoma by screening colonoscopy with polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to account for up to 10.5% of CRC. a CRC has been associated with proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination, incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR). High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC. Bowel preparation includes diet restriction and proper use of laxative before the colonoscopy, and this is one of the important factors to ensure a high quality colonoscopy. Suboptimal bowel preparation may lead to decreased ADR, cecal intubation rate, and surveillance interval and increased procedural time. Efforts to improve bowel cleansing quality through traditional communication routines, including face-to-face verbal education, written booklet or visual aids or telephone-based re-instruction have proven to be useful. A recent study using WeChat, a widely used social media mobile app in China, has also shown to be effectively improving bowel preparation level of a mixed population who received diagnostic (77%), screening (15.8%) and surveillance (7.2%) colonoscopy. However, the impact of social media mobile app on the bowel preparation level of screening colonoscopy is not yet known. Hence, this study will investigate the effectiveness of the most popular social media app worldwide, WhatsApp in bowel preparation level of screening colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
666

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

July 4, 2017

Last Update Submit

June 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bowel preparation level

    Proportion of subjects having optimal bowel preparation level

    Immediate after colonoscopy

Secondary Outcomes (3)

  • Polyp detection rate

    Immediate after colonoscopy

  • adenoma detection rate

    a month after colonoscopy

  • Mean number of adenoma detected per patient

    1 year after study started, i.e. when all subjects undergo colonoscopy

Study Arms (2)

WhatsApp reminder

ACTIVE COMPARATOR

An additional WhatsApp reminder with same content of the written instruction and a video of explanation of bowel preparation by a nurse 4 days prior colonoscopy

Other: WhatsApp reminder

No reminder

NO INTERVENTION

No additional reminder will be given

Interventions

An additional WhatsApp reminder with same content of the written instruction and a video of explanation of bowel preparation by a nurse 4 days prior colonoscopy

WhatsApp reminder

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects arranged for an out-patient screening colonoscopy in Prince of Wales Hospital and Alice Ho Miu Ling Hospital.

You may not qualify if:

  • Lack of access to WhatsApp Messenger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lam TYT, Wu PI, Tang RSY, Tse YK, Lau JYW, Wu JCY, Sung JJY. Nurse-led reinforced education by mobile messenger improves the quality of bowel preparation of colonoscopy in a population-based colorectal cancer screening program: A randomized controlled trial. Int J Nurs Stud. 2022 Sep;133:104301. doi: 10.1016/j.ijnurstu.2022.104301. Epub 2022 May 30.

Study Officials

  • Thomas Yuen Tung Lam, MSc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Endoscopists will be masked if the patients have received WhatsApp reminder prior colonoscopy
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Officer

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 6, 2017

Study Start

June 2, 2017

Primary Completion

April 17, 2019

Study Completion

December 31, 2019

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations