NCT01267877

Brief Summary

The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. The population studied was women seeing their private gynecologist for annual exams in the 39-49 year old age group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2010

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

December 22, 2010

Last Update Submit

January 4, 2017

Conditions

Keywords

U.S. Preventive Services Task ForcePatient attitudeMammogramGuideline

Outcome Measures

Primary Outcomes (1)

  • Willingness to forgo mammograms from age 40-49

    within 15 minutes of completion of reading assigned article

Secondary Outcomes (3)

  • Do you feel that the mammogram recommendations safe?

    within 15 minutes of completion of reading assigned article

  • Do attitudes regarding the breast cancer screening guidelines differ by acquaintance with breast cancer?

    within 15 minutes of completion of reading assigned article

  • Does willingness to forgo mammograms in their 40's differ by previous "false alarms" with mammography?

    within 15 minutes of completion of reading assigned article

Study Arms (2)

Guideline unfavorable article

ACTIVE COMPARATOR
Other: read unfavorable article prior to answering questions

Guideline favorable article

ACTIVE COMPARATOR
Other: read favorable article prior to answering questions

Interventions

article title: "Taking a hit on healthcare- why that's women's work"

Also known as: Boston Globe, November 19, 2009; Section A17. Joan Vennochi.
Guideline unfavorable article

read "A Backlash of Mistrust"

Also known as: Washington Post; November 25, 2009. Ellen Goodman.
Guideline favorable article

Eligibility Criteria

Age39 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women aged 39-49 seeing their gynecologist for routine preventive care

You may not qualify if:

  • women not aged 39-49
  • women with breast cancer
  • women not able to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UMassMemorial Medical Group- Auburn Gyn

Auburn, Massachusetts, 01501, United States

Location

Shrewsbury Ob-Gyn

Shrewsbury, Massachusetts, 01545, United States

Location

UMassMemorial Medical Group- OB-GYN

Shrewsbury, Massachusetts, 01545, United States

Location

Women's Health of Central Mass

Worcester, Massachusetts, 01608, United States

Location

MeSH Terms

Conditions

BehaviorBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dale Magee, M.D., M.S.

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR
  • AuTumn Davidson, M.D.

    University of Massachusetts, Worcester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 29, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations