NCT00459030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
904

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

7.2 years

First QC Date

April 9, 2007

Last Update Submit

August 16, 2013

Conditions

Colorectal Cancer

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

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

    End of study

Secondary Outcomes (2)

  • Moderating role of attentional style and background variables on the impact of the interventions

    End of Study

  • Mediating effect of potential cognitive-affective factors related to CRC screening

    End of study

Study Arms (3)

Print Communication

EXPERIMENTAL

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

Other: educational intervention mailed

Electronic communication

EXPERIMENTAL

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

Other: educational intervention via internet

No Health Communication

ACTIVE COMPARATOR

No additional cancer screening education information sent to patient.

Other: No additional educational intervention

Interventions

educational intervention via internetOTHER

additional cancer screening information via password protected internet site

Electronic communication
educational intervention mailedOTHER
Print Communication
No additional educational interventionOTHER
No Health Communication

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related 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.

    PMID: 23128366RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David Weinberg, MD, MSC

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

October 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

US(1)