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

Colorectal Neoplasms Clinical Trial

— SSN  

Official title:

Initiation of Colon Cancer Screening in Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079533
• Other study ID #: R01CA112223-01A2
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: May 2, 2017
• Start date: July 2008
• Est. completion date: July 31, 2014

Study information

• Verified date: May 2017
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Colorectal cancer (CRC) is the 2nd leading cause of cancer deaths in the US and risk increases with age. Colorectal cancer screening (CRCS) offers the possibility of both early detection and prevention. For those at average risk, CRCS beginning at age 50 is recommended. However, awareness and use of CRCS tests are low. We propose to conduct a randomized controlled trial to develop and test stepped interventions to increase initial uptake of CRCS in a nationally-representative, ethnically-diverse sample of male and female veterans. Our specific aims are to: (1) develop and pre-test stepped intervention components that are theory and evidence-informed; (2) implement and evaluate the process, efficacy, and cost-effectiveness of stepped interventions to increase an initial CRCS among male and female veterans aged 50-64 years; and (3) analyze the association between predictor variables and CRCS initiation and the mediating and moderating effects of the interventions, after each step. In Step 1, we will evaluate a theory-based minimal cue delivered by a letter, telephone call, or automated telephone call compared with a survey-only control group to determine whether the 3 different delivery channels are equally efficacious and cost-effective. Minimal cues are a cost-effective method that prompts to action those more willing to change and are easy to disseminate in real-world settings. Persons who do not complete CRCS in Step 1 will be randomized in Step 2 to more intensive interventions that address resistance. In Step 2 we will determine whether a theory-based, tailored telephone intervention, using principles of Motivation Interviewing, is effective when delivered as part of a sequential intervention process in which early adopters have been removed from the population. 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. After each step, we will examine the mediating and moderating effects of the intervention to identify determinants of completion. For cancer screening intervention research to have the broadest public health impact, interventions must have the potential for dissemination. We designed our trial to move us toward the goal of disseminable interventions with evidence of external validity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1892
• Est. completion date: July 31, 2014
• Est. primary completion date: November 3, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or Female Veteran age 50 to 64

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms

Intervention

Behavioral:
• Stepped CRCS Interventions
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.
• Control
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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston School of Public Health	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Boston University, Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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