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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marc D Schwartz, Georgetown University
ClinicalTrials.gov Identifier:
NCT00262899
First received: December 6, 2005
Last updated: January 4, 2013
Last verified: January 2013
  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
Psychosocial Effects of Cancer and Its Treatment
Behavioral: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Genetic Counseling for Newly Diagnosed Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization [ Time Frame: 1, 6, and 12 months ] [ 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 [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
  • Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
  • Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization [ Time Frame: 1 and 6 months ] [ Designated as safety issue: No ]

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

Enrollment: 331
Study Start Date: August 2005
Study Completion Date: July 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapid genetic counseling
Following randomization, participants will be informed about whether they are assigned to Usual Care (UC) or Rapid Genetic Counseling (RGC). Participants in the UC arm can schedule a genetic counseling appointment at any time during the study if they wish. Participants in the RGC agree to obtain genetic counseling as soon as possible, before they make a definitive surgery decision. RGC can be accomplished by telephone or in-person. The RGC intervention is delivered by highly experienced genetic counselors at each site. This counseling is identical to our standard genetic counseling procedure for newly diagnosed patients. Immediate DNA collection via blood or buccal cell collection is available following counseling. Phone counseling participants will be been mailed a kit for DNA collection or have the option of having the sample collected at at LCCC.
Behavioral: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care
No Intervention: Usual Care
Usual Care (UC) for newly diagnosed breast cancer patients does not typically include a pre-surgical genetic referral. These patients may obtain genetic counseling at their own discretion.

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Washington, District of Columbia, United States, 20007
United States, Maryland
Chevy Chase, Maryland, United States, 20815
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Georgetown University
Investigators
Study Chair: Marc Schwartz, PhD Lombardi Cancer Research Center
  More Information

No publications provided

Responsible Party: Marc D Schwartz, Professor of Oncology, Georgetown University
ClinicalTrials.gov Identifier: NCT00262899     History of Changes
Other Study ID Numbers: CDR0000450155, R01CA108933, R01CA074861, P30CA051008, GUMC-2004-212
Study First Received: December 6, 2005
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on August 19, 2014