Breast Cancer Screening Via Computer V. Phone

Breast Cancer Screening Clinical Trial

Official title:

Breast Cancer Screening Via Computer V. Phone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287040
• Other study ID #: 0408-03B
• Secondary ID: R01NR008434NIH:
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2006
• Last updated: May 16, 2012
• Start date: September 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2008
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1686
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 41 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer Screening
• Breast Neoplasms

Intervention

Behavioral:
• Tailored, interactive intervention for mammography screening
Follow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Indiana University	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To increase annual mammography adherence		at 6-, 12-, and 21-Months	No
Secondary	Cost-effectiveness of DVD versus telephone survey		at 6-, 12-, and 21-months	No