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Clinical Trials/NCT00287040
NCT00287040
Completed
Phase 3

Breast Cancer Screening Via Computer V. Phone

Indiana University2 sites in 1 country1,686 target enrollmentSeptember 2007

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Breast Cancer Screening
Sponsor
Indiana University
Enrollment
1686
Locations
2
Primary Endpoint
To increase annual mammography adherence
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is to compare mammography adherence among women receiving tailored, interactive mammography interventions via DVD and telephone counseling to usual care.

Detailed Description

Efficacy Study - We will use stratified block randomization based on race to ensure that the treatment groups maintain comparable race composition. Participants will be randomly assigned to one of the intervention groups or to usual care. Intervention Group 1 will receive, by mail, a DVD version of the interactive computer program; based on responses to its queries, the program will supply immediate feedback to promote mammography. Intervention Group 2 will receive a telephone version of the tailored intervention delivered by a counselor stationed at a computer. The counselor will use questions from the interactive program and deliver messages the program generates in response to each woman's answers. A third group will receive usual care. All women will be asked to participate in 6-month and 21-month follow-up telephone interviews querying stage of mammography adherence and beliefs.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
June 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • • Must have been a member of their HMO/insurance plan for at least 15 months with records indicating no mammogram (screening or diagnostic) in that 15-month period
  • Current member of the plan at time of study enrollment
  • No history of breast cancer diagnosis
  • Complete telephone number and mailing address

Exclusion Criteria

  • • Any claim submitted for a mammogram (screening or diagnostic) in the last 15 months within the HMO/insurance plan or an outside source
  • Previous breast cancer diagnosis
  • Incomplete telephone number or mailing address

Outcomes

Primary Outcomes

To increase annual mammography adherence

Time Frame: at 6-, 12-, and 21-Months

Secondary Outcomes

  • Cost-effectiveness of DVD versus telephone survey(at 6-, 12-, and 21-months)

Study Sites (2)

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