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

Georgetown University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Psychosocial Effects of Cancer and Its Treatment

Treatments: Other: educational intervention; Behavioral: counseling intervention; Procedure: psychosocial assessment and care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00262899

CDR0000450155

P30CA051008 (U.S. NIH Grant/Contract)

R01CA108933 (U.S. NIH Grant/Contract)

GUMC-2004-212

R01CA074861 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 331 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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331 participants in 2 patient groups

Rapid genetic counseling

Experimental group

Description:

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.

Treatment:

Other: educational intervention

Procedure: psychosocial assessment and care

Behavioral: counseling intervention

Usual Care

No Intervention group

Description:

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.