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

Sponsors and Collaborators:	Fox Chase Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00459030

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: counseling intervention

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized
Official Title:	Two Delivery Channels to Improve CRC Screening

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates [ Designated as safety issue: No ]
Moderating role of attentional style and background variables on the impact of the interventions [ Designated as safety issue: No ]
Mediating effect of potential cognitive-affective factors related to CRC screening [ Designated as safety issue: No ]
Cost-effectiveness of interventions [ Designated as safety issue: No ]

Estimated Enrollment:	5000
Study Start Date:	October 2005
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459030

Locations

United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790

Sponsors and Collaborators

Fox Chase Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

David Weinberg, MD, MSC

Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000538413, FCCC-05016, FCCC-IRB-05-016
Study First Received:	April 9, 2007
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00459030 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases

Rectal Neoplasm
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009