Clinical trial NCT00459030: Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening
Official title: Two Delivery Channels to Improve CRC Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-11
Enrollment: 904
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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

Primary outcomes:
measure: Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates
timeFrame: End of study
Secondary outcomes:
measure: Moderating role of attentional style and background variables on the impact of the interventions
timeFrame: End of Study
measure: Mediating effect of potential cognitive-affective factors related to CRC screening
timeFrame: End of study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: David Weinberg, MD, MSC
role: STUDY_CHAIR
References:
citation: 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.