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

August 16, 2013 updated by: Fox Chase Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

904

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Moderating role of attentional style and background variables on the impact of the interventions
Time Frame: End of Study
End of Study
Mediating effect of potential cognitive-affective factors related to CRC screening
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David Weinberg, MD, MSC, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 9, 2007

First Submitted That Met QC Criteria

April 9, 2007

First Posted (Estimate)

April 11, 2007

Study Record Updates

Last Update Posted (Estimate)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCCC-05016
  • CDR0000538413 (Registry Identifier: PDQ (Physician Data Query))
  • IRB05-016 (Other Identifier: Fox Chase Cancer Center)
  • R01CA102695 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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