NCT00165152

Brief Summary

To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jul 1998

Longer than P75 for not_applicable breast-cancer

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

Study Start

First participant enrolled

July 1, 1998

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

3.2 years

First QC Date

September 9, 2005

Last Update Submit

August 7, 2012

Conditions

Breast CancerOvarian Cancer

Keywords

Genetic testingBRCA1 geneBRCA2 geneCounseling interventionsGenetic counseling

Outcome Measures

Primary Outcomes (1)

  • To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing.

    5 years

Secondary Outcomes (1)

  • To compare the financial costs incurred in the implementation of the two models and examine the utilization of medical and mental health services by participants in each condition during the follow-up period.

    5 years

Study Arms (2)

Genetic Counseling

ACTIVE COMPARATOR
Procedure: Genetic Counseling

Informed Consent Counseling

ACTIVE COMPARATOR
Procedure: Informed Consent Counseling

Interventions

Genetic CounselingPROCEDURE

Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.

Genetic Counseling
Informed Consent CounselingPROCEDURE

Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.

Informed Consent Counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
  • Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
  • Documentation of key family member cancer diagnoses is required

You may not qualify if:

  • Males, will be offered BRCA 1/2 testing through other protocols
  • Individuals unable to speak or write English
  • Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
  • Life expectancy of less than 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsFanconi Anemia, Complementation Group D1

Interventions

Genetic Counseling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Genetic ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Judy Garber, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 1998

Primary Completion

September 1, 2001

Study Completion

June 1, 2005

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

US(2)