Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00459030
First received: April 9, 2007
Last updated: August 16, 2013
Last verified: August 2013

April 9, 2007
August 16, 2013
October 2005
December 2012   (final data collection date for primary outcome measure)
Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates [ Time Frame: End of study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00459030 on ClinicalTrials.gov Archive Site
  • Moderating role of attentional style and background variables on the impact of the interventions [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Mediating effect of potential cognitive-affective factors related to CRC screening [ Time Frame: End of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening
Two Delivery Channels to Improve CRC Screening

RATIONALE: Finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. It is not yet known which communication method is more effective in increasing how often participants undergo colorectal cancer screening.

PURPOSE: This randomized clinical trial is studying traditional print communication methods to see how well they work compared with simple electronic communication methods or usual care in increasing how often older women undergo colorectal cancer screening.

OBJECTIVES:

  • Compare traditional print versus simple electronic communication versus usual care, in terms of increasing colorectal cancer (CRC) screening rates, in average-risk women attending a routine OB/Gyn visit.
  • Explore the moderating role of attentional style and background variables on the impact of the interventions in these participants.
  • Determine the mediating effect of potential cognitive-affective factors related to CRC screening in these participants.
  • Investigate the comparative cost-effectiveness of these interventions to improve CRC screening adherence.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 screening arms.

  • Arm I: Participants are contacted by simple electronic communication methods by an email message linked to a personalized website.
  • Arm II: Participants are contacted by traditional print communication methods.
  • Arm III: Participants are observed (usual care). Participants in arms I and II are randomized a second time to receive messages about colorectal cancer screening that are matched or mismatched to their attentional style.

PROJECTED ACCRUAL: A total of 5,000 participants will be accrued for this study.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Colorectal Cancer
  • Other: educational intervention via internet
    additional cancer screening information via password protected internet site
  • Other: educational intervention mailed
  • Other: No additional educational intervention
  • Experimental: Print Communication
    Cancer screening educational information mailed to patient's home one time after signing consent.
    Intervention: Other: educational intervention mailed
  • Experimental: Electronic communication
    Cancer screening educational information delivered via a password protected internet site.
    Intervention: Other: educational intervention via internet
  • Active Comparator: No Health Communication
    No additional cancer screening education information sent to patient.
    Intervention: Other: No additional educational intervention
Weinberg DS, Keenan E, Ruth K, Devarajan K, Rodoletz M, Bieber EJ. A randomized comparison of print and web communication on colorectal cancer screening. JAMA Intern Med. 2013 Jan 28;173(2):122-9. doi: 10.1001/2013.jamainternmed.1017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
904
December 2012
December 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • At average risk for colorectal cancer (CRC) as defined by the following criteria:

    • Asymptomatic without a personal history of colorectal polyps or cancer
    • No inflammatory bowel disease
    • No family history of familial adenomatous polyposis or hereditary nonpolyposis CRC
    • No CRC in more than one first-degree relative
  • Nonadherent with standard CRC screening recommendations at the time of index OB/Gyn appointment

PATIENT CHARACTERISTICS:

  • Email accessible at home and/or work
  • Able to communicate with ease in English

PRIOR CONCURRENT THERAPY:

  • Not specified
Female
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00459030
FCCC-05016, CDR0000538413, IRB05-016, R01CA102695
No
Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
Fox Chase Cancer Center
August 2013

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