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

NCT ID: NCT00459030

Last Updated: 2013-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

904 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Keywords

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colon cancer rectal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Print Communication

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

Group Type EXPERIMENTAL

educational intervention mailed

Intervention Type OTHER

Electronic communication

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

Group Type EXPERIMENTAL

educational intervention via internet

Intervention Type OTHER

additional cancer screening information via password protected internet site

No Health Communication

No additional cancer screening education information sent to patient.

Group Type ACTIVE_COMPARATOR

No additional educational intervention

Intervention Type OTHER

Interventions

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educational intervention via internet

additional cancer screening information via password protected internet site

Intervention Type OTHER

educational intervention mailed

Intervention Type OTHER

No additional educational intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Weinberg, MD, MSC

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

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Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23128366 (View on PubMed)

Other Identifiers

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CDR0000538413

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB05-016

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA102695

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FCCC-05016

Identifier Type: -

Identifier Source: org_study_id