NCT00349011

Brief Summary

The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2002

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

Study Start

First participant enrolled

August 1, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

First QC Date

July 5, 2006

Last Update Submit

August 29, 2023

Conditions

Menopause

Keywords

menopausegenetic counselingbreast cancertamoxifenchemoprevention

Outcome Measures

Primary Outcomes (4)

  • Decisional conflict

  • Knowledge of menopause and menopausal therapy

  • Satisfaction with counseling intervention

  • Medication usage

Secondary Outcomes (2)

  • Perceived risk of breast cancer, heart disease, osteoporosis

  • Worry about breast cancer, heart disease, osteoporosis

Interventions

Personalized risk assessmentPROCEDURE
genetic counseling interventionPROCEDURE

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least one first degree relative with breast cancer
  • age 40 or older

You may not qualify if:

  • currently taking a menopausal therapy
  • previous cancer diagnosis (except basal cell carcinoma)
  • previous diagnosis of atypical hyperplasia
  • previous diagnosis of lobular carcinoma in situ (LCIS)
  • known carrier of a BRCA1 or BRCA2 mutation
  • personal history of heart disease
  • \>10% risk of carrying a BRCA1 or BRCA2 mutation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ellen T. Matloff, M.S.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

August 1, 2002

Study Completion

March 1, 2004

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)