NCT00347568

Brief Summary

The purpose of this study is to develop a web-based decision aid to help women at high risk for breast cancer make informed breast cancer prevention choices. These choices include chemoprevention, surgery, genetic counseling, or regular screening in accordance with recommended guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

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

June 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

June 29, 2006

Last Update Submit

June 4, 2012

Conditions

Breast Cancer

Keywords

decision aidshigh riskbreast cancerbreast cancer prevention

Outcome Measures

Primary Outcomes (1)

  • Usability feedback on new decision aid for women at high risk for breast cancer from patients and physicians.

    9/01/06-8/31/07

Interventions

TX-ploreDEVICE

PI has terminated at institution and there is no one available to report.

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between the ages of 21 - 75
  • at least one first degree relative with breast cancer or a Gail Model score signifying high risk
  • female
  • having had contact with a PCP (physician or nurse practitioner)within the last year
  • being a patient at a participating clinic (for usability and pilot study)

You may not qualify if:

  • Inability to give informed, voluntary consent
  • History of breast cancer or LCIS
  • Language, vision, or reading difficulties, or non-English speaking
  • Pregnancy
  • women over 75 because of the lack of data guiding the impact of preventive treatments among this age group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nananda Col, MD, MPP, MPH

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2007

Study Completion

December 1, 2009

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

US(1)