Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00459030
First received: April 9, 2007
Last updated: June 9, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer
 Other: counseling intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Health Services Research
Official Title: Two Delivery Channels to Improve CRC Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates [ Designated as safety issue: No ]
  • Moderating role of attentional style and background variables on the impact of the interventions [ Designated as safety issue: No ]
  • Mediating effect of potential cognitive-affective factors related to CRC screening [ Designated as safety issue: No ]
  • Cost-effectiveness of interventions [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: October 2005
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459030

Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi     215-728-4790        
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00459030     History of Changes
Other Study ID Numbers: CDR0000538413, FCCC-05016, FCCC-IRB-05-016
Study First Received: April 9, 2007
Last Updated: June 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

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

ClinicalTrials.gov processed this record on June 18, 2013