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Clinical Trials (PDQ®)

  • First Published: 4/2/2007
  • Last Modified: 5/7/2007

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Randomized Study of Traditional Print Versus Simple Electronic Communication Versus Usual Care to Improve Colorectal Cancer Screening Compliance in Older Women

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBehavioral study, Health services research, ScreeningActive50 and overNCIFCCC-05016
05-016, FCCC-IRB-05-016, NCT00459030

Objectives

  1. 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.
  2. Explore the moderating role of attentional style and background variables on the impact of the interventions in these participants.
  3. Determine the mediating effect of potential cognitive-affective factors related to CRC screening in these participants.
  4. Investigate the comparative cost-effectiveness of these interventions to improve CRC screening adherence.

Entry 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

Prior/Concurrent Therapy:

  • Not specified

Patient Characteristics:

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

Expected Enrollment

5000

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

Outcomes

Primary Outcome(s)

Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates
Moderating role of attentional style and background variables on the impact of the interventions
Mediating effect of potential cognitive-affective factors related to CRC screening
Cost-effectiveness of interventions

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.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

David Weinberg, MD, MSC, Protocol chair
Ph: 215-214-1424; 888-369-2427

Trial Sites

U.S.A.
Pennsylvania
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790

Registry Information
Official Title Two Delivery Channels to Improve CRC Screening
Trial Start Date 2005-10-10
Trial Completion Date 2010-10-10 (estimated)
Registered in ClinicalTrials.gov NCT00459030
Date Submitted to PDQ 2007-03-01
Information Last Verified 2009-06-07
NCI Grant/Contract Number CA06927, CA102695

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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