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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


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
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