Initiation of Colon Cancer Screening in Veterans or "Start Screening Now" (SSN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Duke University
Boston University
Information provided by (Responsible Party):
Sally Vernon, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01079533
First received: February 26, 2010
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Behavioral: Stepped CRCS Interventions
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Initiation of Colon Cancer Screening in Veterans

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Colorectal Cancer Screening [ Time Frame: 9 month follow up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1504
Study Start Date: July 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: 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.
Experimental: Minimal Cue and TLC
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
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.
Other Name: Start Screening Now

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.

  Eligibility

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079533

Locations
United States, Texas
University of Texas Health Science Center at Houston School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Duke University
Boston University
Investigators
Principal Investigator: Sally W Vernon, PhD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: Sally Vernon, Professor - Health Promotion and Behavioral Science, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01079533     History of Changes
Other Study ID Numbers: R01 CA112223-01A2
Study First Received: February 26, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Colorectal Neoplasms
Mass Screening
Patient Compliance
Intervention Studies
Clinical Trial

Additional relevant MeSH terms:
Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 20, 2014