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

Breast Cancer Clinical Trial

Official title:

Genetic Counseling for Newly Diagnosed Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262899
• Other study ID #: CDR0000450155
• Secondary ID: R01CA108933R01CA
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2005
• Last updated: January 4, 2013
• Start date: August 2005
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Behavioral:
• counseling intervention

Other:
• educational intervention

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	Mount Sinai School of Medicine	New York	New York
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization		1, 6, and 12 months	No
Primary	Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization		1, 6, and 12 months	No
Primary	Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization		1, 6, and 12 months	No
Primary	Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization		1 month	No
Primary	Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization		1 and 6 months	No
Secondary	Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization		12 months	No