NCT00287040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,686

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 17, 2012

Status Verified

August 1, 2008

Enrollment Period

1.8 years

First QC Date

February 3, 2006

Last Update Submit

May 16, 2012

Conditions

Breast Cancer Screening

Keywords

Breast CancerMammography

Outcome Measures

Primary Outcomes (1)

  • To increase annual mammography adherence

    at 6-, 12-, and 21-Months

Secondary Outcomes (1)

  • Cost-effectiveness of DVD versus telephone survey

    at 6-, 12-, and 21-months

Study Arms (3)

1 - Usual Care

NO INTERVENTION

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

2. DVD Intervention

EXPERIMENTAL

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

3. Telephone Counseling

EXPERIMENTAL

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

Interventions

Tailored, interactive intervention for mammography screeningBEHAVIORAL

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

2. DVD Intervention3. Telephone Counseling

Eligibility Criteria

Age41 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Duke University

Durham, North Carolina, United States

Location

Related Publications (2)

  • 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.

    PMID: 26416127DERIVED

  • 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.

    PMID: 25070967DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Victoria Champion, DNS

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 17, 2012

Record last verified: 2008-08

Locations

US(2)