Breast Cancer Screening Via Computer V. Phone

Phase 3

Completed

• Conditions: Breast Cancer Screening
• Interventions: Behavioral: Tailored, interactive intervention for mammography screening

• Registration Number: NCT00287040
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-06
• Study Start: 2007-09
• Status Verified: 2008-08
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1686

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2. DVD Intervention	Tailored, interactive intervention for mammography screening	This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD.
3. Telephone Counseling	Tailored, interactive intervention for mammography screening	This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling.

Primary Outcome Measures

Name	Time	Method
To increase annual mammography adherence	at 6-, 12-, and 21-Months

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of DVD versus telephone survey	at 6-, 12-, and 21-months

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Duke University; 🇺🇸 Durham, North Carolina, United States