Breast Cancer Screening Via Computer V. Phone

NCT ID: NCT00287040

Last Updated: 2012-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1686 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1 - Usual Care

This arm looks at mammogram adherence in those individuals who at this time are not receiving booster mammogram interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

2. DVD Intervention

This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD.

Group Type EXPERIMENTAL

Tailored, interactive intervention for mammography screening

Intervention Type BEHAVIORAL

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

3. Telephone Counseling

This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling.

Group Type EXPERIMENTAL

Tailored, interactive intervention for mammography screening

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

41 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Champion, DNS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Gathirua-Mwangi WG, Monahan PO, Stump T, Rawl SM, Skinner CS, Champion VL. Mammography Adherence in African-American Women: Results of a Randomized Controlled Trial. Ann Behav Med. 2016 Feb;50(1):70-8. doi: 10.1007/s12160-015-9733-0.

Reference Type DERIVED
PMID: 26416127 (View on PubMed)

Champion VL, Rawl SM, Bourff SA, Champion KM, Smith LG, Buchanan AH, Fish LJ, Monahan PO, Stump TE, Springston JK, Gathirua-Mwangi WG, Skinner CS. Randomized trial of DVD, telephone, and usual care for increasing mammography adherence. J Health Psychol. 2016 Jun;21(6):916-26. doi: 10.1177/1359105314542817. Epub 2014 Jul 28.

Reference Type DERIVED
PMID: 25070967 (View on PubMed)

Other Identifiers

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R01NR008434

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH: R01 NR0083434

Identifier Type: -

Identifier Source: secondary_id

0408-03B

Identifier Type: -

Identifier Source: org_study_id

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