Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01079533
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Duke University
Boston University
Information provided by (Responsible Party):
Sally Vernon, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE February 26, 2010
First Posted Date  ICMJE March 3, 2010
Last Update Posted Date May 3, 2017
Actual Study Start Date  ICMJE July 2008
Actual Primary Completion Date November 3, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
Colorectal Cancer Screening [ Time Frame: 9 month follow up ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Initiation of Colon Cancer Screening in Veterans or "Start Screening Now"
Official Title  ICMJE Initiation of Colon Cancer Screening in Veterans
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Control
  • 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.
    Intervention: Behavioral: Stepped CRCS Interventions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2017)
1892
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2010)
1504
Actual Study Completion Date  ICMJE July 31, 2014
Actual Primary Completion Date November 3, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01079533
Other Study ID Numbers  ICMJE R01CA112223-01A2( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sally Vernon, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE
  • Duke University
  • Boston University
Investigators  ICMJE
Principal Investigator: Sally W Vernon, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP