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Breast Cancer Screening Via Computer V. Phone

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ClinicalTrials.gov Identifier: NCT00287040
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : May 17, 2012
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Screening Behavioral: Tailored, interactive intervention for mammography screening Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1686 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Breast Cancer Screening Via Computer V. Phone
Study Start Date : September 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1 - Usual Care
This arm looks at mammogram adherence in those individuals who at this time are not receiving booster mammogram interventions.
Experimental: 2. DVD Intervention
This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD.
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
Experimental: 3. Telephone Counseling
This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling.
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



Primary Outcome Measures :
  1. To increase annual mammography adherence [ Time Frame: at 6-, 12-, and 21-Months ]

Secondary Outcome Measures :
  1. Cost-effectiveness of DVD versus telephone survey [ Time Frame: at 6-, 12-, and 21-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287040


Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Duke University
Durham, North Carolina, United States
Sponsors and Collaborators
Indiana University
National Institute of Nursing Research (NINR)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Victoria Champion, DNS Indiana University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00287040     History of Changes
Other Study ID Numbers: 0408-03B
R01NR008434 ( U.S. NIH Grant/Contract )
NIH: R01 NR0083434
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: August 2008

Keywords provided by Indiana University:
Breast Cancer
Mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases