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Breast Cancer Screening Via Computer V. Phone

Primary Purpose

Breast Cancer Screening

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tailored, interactive intervention for mammography screening
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Screening focused on measuring Breast Cancer, Mammography

Eligibility Criteria

41 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University
  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1 - Usual Care

2. DVD Intervention

3. Telephone Counseling

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

To increase annual mammography adherence

Secondary Outcome Measures

Cost-effectiveness of DVD versus telephone survey

Full Information

First Posted
February 3, 2006
Last Updated
May 16, 2012
Sponsor
Indiana University
Collaborators
National Institute of Nursing Research (NINR), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00287040
Brief Title
Breast Cancer Screening Via Computer V. Phone
Official Title
Breast Cancer Screening Via Computer V. Phone
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
National Institute of Nursing Research (NINR), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Screening
Keywords
Breast Cancer, Mammography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1686 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Usual Care
Arm Type
No Intervention
Arm Description
This arm looks at mammogram adherence in those individuals who at this time are not receiving booster mammogram interventions.
Arm Title
2. DVD Intervention
Arm Type
Experimental
Arm Description
This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD.
Arm Title
3. Telephone Counseling
Arm Type
Experimental
Arm Description
This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling.
Intervention Type
Behavioral
Intervention Name(s)
Tailored, interactive intervention for mammography screening
Intervention Description
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 Measure Information:
Title
To increase annual mammography adherence
Time Frame
at 6-, 12-, and 21-Months
Secondary Outcome Measure Information:
Title
Cost-effectiveness of DVD versus telephone survey
Time Frame
at 6-, 12-, and 21-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Champion, DNS
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26416127
Citation
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.
Results Reference
derived
PubMed Identifier
25070967
Citation
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.
Results Reference
derived

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Breast Cancer Screening Via Computer V. Phone

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