NCT06185374

Brief Summary

Colorectal cancer is a common but preventable condition, and increasing colorectal cancer screening is one of the most impactful public health contributions in the field of gastroenterology. Text messaging is a simple, cheap, and rapid method to reach patients that may improve adherence to colonoscopy appointments as well as simplify the process of bowel preparation. The purpose of the study is to evaluate the feasibility of a pilot bidirectional text messaging intervention on attendance for screening/surveillance colonoscopy and bowel preparation quality at an urban VA hospital. The goal is to improve adherence to colonoscopy among patients who are due for a repeat colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable colorectal-cancer

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

First Submitted

Initial submission to the registry

December 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 20, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

December 15, 2023

Results QC Date

August 1, 2025

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • National Annie Colonoscopy Survey Score

    7-item assessment of participant satisfaction with the "Annie" text intervention. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate greater satisfaction with the intervention.

    Day 21 (Up to 7 Days Post-Procedure)

Secondary Outcomes (2)

  • Percentage of Participants Who Attend Scheduled Colonoscopy Appointment

    Up to Day 14

  • Percentage of Participants Who Had Adequate Bowel Preparation at Colonoscopy Appointment

    Up to Day 14

Study Arms (2)

Text Message Intervention

EXPERIMENTAL

Participants in the experimental arm will receive a series of instructional and motivational text messages, which will be sent starting 7-14 days before and until the day of the colonoscopy procedure.

Behavioral: Text Message Instructions/Motivation

No Intervention

NO INTERVENTION

Participants will not receive text messages.

Interventions

For instructional messages, earlier messages will remind patients of the colonoscopy appointment and later messages will help patients complete the bowel preparation process in real-time. Motivational messages will be sent along with instructional messages.

Text Message Intervention

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has previously undergone a colonoscopy and is currently due for a repeat screening or surveillance colonoscopy at the VA.

You may not qualify if:

  • Patients not due for screening or surveillance colonoscopy. This will be based on 2020 guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer.
  • Patients with personal history of colorectal cancer (CRC)/inflammatory bowel disease/ hereditary colon cancer syndrome or family history of hereditary colon cancer syndrome. These criteria will be determined based on ICD9/10 codes or the medical record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Harbor Health Care System - Department of Veterans Affairs

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Peter Liang, MD
Organization
NYU Langone Health

Study Officials

  • Peter Liang, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 29, 2023

Study Start

February 27, 2024

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

August 20, 2025

Results First Posted

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: peter.liang@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to peter.liang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations