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Genetic Counseling for Newly Diagnosed Breast Cancer Patients


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Genetic Counseling for Newly Diagnosed Breast Cancer Patients


OBJECTIVES:

- Compare the impact of rapid genetic counseling (RGC) vs usual care on the medical
decisions of women with newly diagnosed ductal carcinoma in situ or stage I-IIIA breast
cancer.

- Compare the impact of these interventions on the quality of life and psychological well
being of these patients.

- Determine baseline factors that predict who is most and least likely to benefit from
RGC in patients undergoing these interventions.

- Compare the cost per quality adjusted life year saved from a societal perspective in
patients undergoing these interventions.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating site. Patients are randomized to 1 of 2 interventional arms.

- Arm I (rapid genetic counseling): Patients undergo a 1½ hour genetic counseling session
either in person or by telephone. Patients who undergo telephone counseling receive a
booklet of visual aids and educational materials. Patient preferences and values are
assessed immediately after counseling. Some patients may undergo BRCA1/2 status
determination. Patients undergo follow-up telephone interviews at 1, 6, and 12 months.

- Arm II (usual care): Patients receive a packet of breast cancer treatment educational
materials. Patient preferences and values are assessed 2 weeks later. Patients undergo
follow-up telephone interviews as in arm I.

In both arms, quality of life is assessed at baseline and at 1, 6, and 12 months.

After completion of the study, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed breast cancer, meeting 1 of the following criteria:

- Stage 0 disease (ductal carcinoma in situ only)

- Stage I-IIIA disease

- Must meet 1 of the following criteria:

- Diagnosis before 50 years of age

- Diagnosis after 50 years of age AND has 1 of the following:

- First or second degree relative diagnosed with breast cancer before 50
years of age

- First or second degree relative diagnosed with ovarian cancer at any age

- First or second degree relative diagnosed with male breast cancer at any
age

- Must not have initiated definitive treatment for breast cancer

- No bilateral, metastatic, or inflammatory breast cancer

- No prior BRCA1/2 counseling or testing

- No prior diagnosis of metastatic cancer of any type

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Sex

- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Surgery

- No prior bilateral mastectomy for breast cancer

Other

- No concurrent treatment for cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization

Outcome Time Frame:

1, 6, and 12 months

Safety Issue:

No

Principal Investigator

Marc Schwartz, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000450155

NCT ID:

NCT00262899

Start Date:

August 2005

Completion Date:

July 2011

Related Keywords:

  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • psychosocial effects of cancer and its treatment
  • ductal breast carcinoma in situ
  • breast cancer in situ
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Baltimore, Maryland  21287