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

Temple University Health System (TUHS)

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: educational intervention via internet; Other: educational intervention mailed; Other: No additional educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00459030

CDR0000538413 (Registry Identifier)

FCCC-05016

R01CA102695 (U.S. NIH Grant/Contract)

IRB05-016 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 904 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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904 participants in 3 patient groups

Print Communication

Experimental group

Description:

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

Treatment:

Other: educational intervention mailed

Electronic communication

Experimental group

Description:

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

Treatment:

Other: educational intervention via internet

No Health Communication

Active Comparator group

Description:

No additional cancer screening education information sent to patient.

Treatment:

Other: No additional educational intervention