Initiation of Colon Cancer Screening in Veterans or "Start Screening Now"

NCT01079533 | Completed DMC

• 1 other identifier: R01CA112223-01A2
• Study Type: interventional
• Target: 1,892
• Locations: 1 country
• Sites: 1

Brief Summary

Initiation of colon cancer screening in veterans is a theory-based stepped intervention to increase first time colorectal cancer screening (CRCS) among male and female veterans age 50 and over.

Conditions

Colorectal Neoplasms

Keywords

Colorectal Neoplasms; Mass Screening; Patient Compliance; Intervention Studies; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Colorectal Cancer Screening

  The primary outcome for the intervention trial is completion of an initial CRCS with 1 of the 5 currently recommended tests or test combinations. There will be one follow up measurement after each intervention step to assess whether uptake of CRCS was completed. The first measure is 9 months after the 1st intervention step. The second is 9 months after the 2nd intervention step.

  9 month follow up

Study Arms (2)

Control

ACTIVE COMPARATOR

A survey-only control arm will be compared to the experimental arm to determine whether the 3 different delivery channels are equally efficacious and cost-effective.

Behavioral: Control

Minimal Cue and TLC

EXPERIMENTAL

Participants randomized to the experimental arm will receive a minimal cue after completing the baseline survey. A follow up survey will be sent 9 months after completion of the minimal cue to assess whether the participant received CRCS. If the participant has not had CRCS they will receive a more intensive telephone linked communication intervention. A second follow up will be sent 9 months after the TLC is delivered to assess final screening status.

Behavioral: Stepped CRCS Interventions

Interventions

Stepped CRCS Interventions BEHAVIORAL

In Step 1, we will evaluate a theory-based minimal cue delivered by a letter, telephone call, or automated telephone call. Persons who do not complete CRCS in Step 1 will be randomized to Step 2 using principles of Motivation Interviewing. Step 2 also will determine whether an automated approach, telephone-linked communication (TLC), is as effective as a telephone counselor in promoting initiation of CRCS. Steps 1 and 2 together will address the important issue of the "dose" needed to encourage completion of CRCS.

Also known as: Start Screening Now

Minimal Cue and TLC

Control BEHAVIORAL

A survey-only control arm will be compared to the experimental arm to determine whether the 3 different delivery channels are equally efficacious and cost-effective.

Control

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female Veteran age 50 to 64

You may not qualify if:

• Prior CRCS
• History of colon or bowel cancer, Crohn's disease, ulcerative colitis
• History of colon polyps
• Currently active duty military
• Outside of age range

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Duke University: collaborator
• Boston University: collaborator

Study Sites (1)

University of Texas Health Science Center at Houston School of Public Health

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Compliance

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sally W Vernon, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Health Promotion and Behavioral Science

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 3, 2010
• Study Start: July 1, 2008
• Primary Completion: November 3, 2011
• Study Completion: July 31, 2014
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)