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| Sponsors and Collaborators: |
National Institute of Nursing Research (NINR) National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institute of Nursing Research (NINR) |
| ClinicalTrials.gov Identifier: | NCT00287040 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Screening |
Behavioral: Tailored, interactive intervention for mammography screening |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment |
| Official Title: | Breast Cancer Screening Via Computer V. Phone |
| Estimated Enrollment: | 1686 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1 - Usual Care: No Intervention
This arm looks at mammogram adherance in those individuals who at this time are not receiving booster mammogram interventions.
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2. DVD Intervention: Experimental
This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD.
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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
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3. Telephone Counseling: Experimental
This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling.
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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
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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.
Eligibility| Ages Eligible for Study: | 41 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
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
Contacts and Locations| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States | |
| Principal Investigator: | Victoria Champion, DNS | Indiana University |
More Information
| Responsible Party: | Indiana University School of Nursing ( Victoria L. Champion, DNS, RN, FAAN, Associate Dean of Research ) |
| Study ID Numbers: | 0408-03B, NIH: R01 NR0083434 |
| Study First Received: | February 3, 2006 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00287040 History of Changes |
| Health Authority: | United States: Federal Government |
|
Breast Cancer Mammography |
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Skin Diseases Breast Neoplasms Breast Diseases |
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Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |
