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
  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: educational intervention via internet
Other: educational intervention mailed
Other: No additional educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Two Delivery Channels to Improve CRC Screening

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 904
Study Start Date: October 2005
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Print Communication
Cancer screening educational information mailed to patient's home one time after signing consent.
Other: educational intervention mailed
Experimental: Electronic communication
Cancer screening educational information delivered via a password protected internet site.
Other: educational intervention via internet
additional cancer screening information via password protected internet site
Active Comparator: No Health Communication
No additional cancer screening education information sent to patient.
Other: No additional educational intervention

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
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: NCT00459030

Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: David Weinberg, MD, MSC Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00459030     History of Changes
Other Study ID Numbers: FCCC-05016, CDR0000538413, IRB05-016, R01CA102695
Study First Received: April 9, 2007
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
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 July 20, 2014