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Initiation of Colon Cancer Screening in Veterans or Start Screening Now

Initiation of Colon Cancer Screening in Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01079533
Acronym
SSN
Enrollment
1892
Registered
2010-03-03
Start date
2008-07-31
Completion date
2014-07-31
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

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

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.

Detailed 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.

Interventions

BEHAVIORALStepped 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.

BEHAVIORALControl

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.

Sponsors

Duke University
CollaboratorOTHER
Boston University
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Colorectal Cancer Screening9 month follow upThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026