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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention via internet
educational intervention mailed
No additional educational intervention
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Fox Chase Cancer Center - Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Print Communication

Electronic communication

No Health Communication

Arm Description

Cancer screening educational information mailed to patient's home one time after signing consent.

Cancer screening educational information delivered via a password protected internet site.

No additional cancer screening education information sent to patient.

Outcomes

Primary Outcome Measures

Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2007
Last Updated
August 16, 2013
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00459030
Brief Title
Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening
Official Title
Two Delivery Channels to Improve CRC Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
904 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Print Communication
Arm Type
Experimental
Arm Description
Cancer screening educational information mailed to patient's home one time after signing consent.
Arm Title
Electronic communication
Arm Type
Experimental
Arm Description
Cancer screening educational information delivered via a password protected internet site.
Arm Title
No Health Communication
Arm Type
Active Comparator
Arm Description
No additional cancer screening education information sent to patient.
Intervention Type
Other
Intervention Name(s)
educational intervention via internet
Intervention Description
additional cancer screening information via password protected internet site
Intervention Type
Other
Intervention Name(s)
educational intervention mailed
Intervention Type
Other
Intervention Name(s)
No additional educational intervention
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Moderating role of attentional style and background variables on the impact of the interventions
Time Frame
End of Study
Title
Mediating effect of potential cognitive-affective factors related to CRC screening
Time Frame
End of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Weinberg, MD, MSC
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23128366
Citation
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.
Results Reference
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Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening

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