NCT05004376

Brief Summary

In this project, we intend to conduct a randomized pilot trial of a structured behavioral intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening recommendations. We will also collect qualitative feedback on perceptions of the intervention to inform its refinement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2022

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

July 28, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 28, 2021

Last Update Submit

July 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Screening

    Rates of completed or scheduled screening

    150 days

Secondary Outcomes (1)

  • Phone Interview for refinement of Intervention

    150 days

Study Arms (2)

Non-adherent control

NO INTERVENTION

Control subjects will receive no text intervention and a 150 day follow-up phone call.

Non-adherent intervention

EXPERIMENTAL

Intervention subjects will receive the text messaging intervention and a 150 day follow-up phone call.

Behavioral: Text Messaging

Interventions

Text MessagingBEHAVIORAL

Text messages based on behavioral theory to encourage scheduling colorectal cancer screening.

Non-adherent intervention

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Present at Strong Memorial Hospital or Noyes Community Hospital Emergency Departments
  • Age 45-75
  • English or Spanish speaking
  • Capacity to consent

You may not qualify if:

  • Personal and/or family history of colorectal cancer
  • Personal history of inflammatory bowel disease
  • History of abdominal or pelvic radiation to treat a prior cancer
  • Non-English and Non-Spanish speaking
  • Inability to consent
  • Lack of text-capable mobile phone and/or inability to use text function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strong Hospital

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Abar B, Park CS, Wood N, Marino D, Fiscella K, Adler D. Intervention to increase colorectal cancer screening among emergency department patients: results from a randomised pilot study. Emerg Med J. 2024 Jun 20;41(7):422-428. doi: 10.1136/emermed-2023-213761.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with a prospectively collected convenience sample
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 13, 2021

Study Start

January 3, 2022

Primary Completion

May 31, 2022

Study Completion

June 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations