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

Colorectal Cancer Clinical Trial

Official title:

Two Delivery Channels to Improve CRC Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459030
• Other study ID #: FCCC-05016
• Secondary ID: CDR0000538413IRB
• Status: Completed
• Phase: N/A
• First received: April 9, 2007
• Last updated: August 16, 2013
• Start date: October 2005
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 904
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• educational intervention via internet
additional cancer screening information via password protected internet site
• educational intervention mailed

• No additional educational intervention

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates		End of study	No
Secondary	Moderating role of attentional style and background variables on the impact of the interventions		End of Study	No
Secondary	Mediating effect of potential cognitive-affective factors related to CRC screening		End of study	No