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

December 6, 2005
January 4, 2013
August 2005
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00262899 on ClinicalTrials.gov Archive Site
Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Genetic Counseling for Newly Diagnosed Breast Cancer Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Behavioral: counseling intervention
  • Other: educational intervention
  • Procedure: psychosocial assessment and care
  • 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.
    Interventions:
    • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
July 2011
July 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262899
CDR0000450155, R01CA108933, R01CA074861, P30CA051008, GUMC-2004-212
No
Marc D Schwartz, Georgetown University
Georgetown University
National Cancer Institute (NCI)
Study Chair: Marc Schwartz, PhD Lombardi Cancer Research Center
Georgetown University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP