Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Genetic Counseling or Usual Care in Helping Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I, Stage II, or Stage IIIA Breast Cancer Make Treatment Decisions
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Lombardi Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262899
  Purpose

RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer.

PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.


Condition Intervention Phase
Breast Cancer
Cancer-Related Problem/Condition
Procedure: counseling
Procedure: educational intervention
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Genetic Counseling
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized
Official Title: Genetic Counseling for Newly Diagnosed Breast Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization [ Designated as safety issue: No ]
  • Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization [ Designated as safety issue: No ]
  • Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization [ Designated as safety issue: No ]
  • Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization [ Designated as safety issue: No ]
  • Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: August 2005
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 follwing 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262899

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center     202-444-0381        
United States, Maryland
Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Colette M. Magnant, MD     301-654-8060     jordanmagnant@yahoo.com    
United States, New Jersey
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Clinical Trials Office - Mount Sinai School of Medicine     212-659-8050        
Sponsors and Collaborators
Lombardi Cancer Research Center
Investigators
Study Chair: Marc Schwartz, PhD Lombardi Cancer Research Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center ( Marc Schwartz )
Study ID Numbers: CDR0000450155, GUMC-2004-212
Study First Received: December 6, 2005
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00262899  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
psychosocial effects/treatment
ductal breast carcinoma in situ
breast cancer in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:
Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on January 30, 2009