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CompletedNCT00165152Updated Aug 9, 2012

Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

An interventional study of Genetic Counseling and Informed Consent Counseling in Breast Cancer and Ovarian Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-09.

Sponsored by Dana-Farber Cancer Institute · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description
  • Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
  • Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
  • Patients will be randomized into one of two counseling groups. 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.
  • Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
  • In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.
02

Conditions studied

  • Breast Cancer
  • Ovarian Cancer

Keywords

  • Genetic testing
  • BRCA1 gene
  • BRCA2 gene
  • Counseling interventions
  • Genetic counseling
03

In context

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 18 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Genetic Counseling

    Procedure: Genetic Counseling

  • Active comparator
    Informed Consent Counseling

    Procedure: Informed Consent Counseling

Interventions

  • ProcedureGenetic Counseling

    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.

  • ProcedureInformed Consent Counseling

    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.

06

What researchers measure

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.

    Time frame: 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.

    Time frame: 5 years

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00165152
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Medical University of South Carolina, National Cancer Institute (NCI)
Responsible party
Judy E. Garber, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 14, 2005
Start date
Jul 1998
Primary completion
Sep 2001
Completion
Jun 2005
Last update
Aug 9, 2012

Study contacts

Judy Garber, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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