Clinical trial NCT00262899: 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
Official title: Genetic Counseling for Newly Diagnosed Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: 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
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-12-07
Enrollment: 331
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization
timeFrame: 1, 6, and 12 months
measure: Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization
timeFrame: 1, 6, and 12 months
measure: Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization
timeFrame: 1, 6, and 12 months
measure: Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization
timeFrame: 1 month
measure: Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization
timeFrame: 1 and 6 months
Secondary outcomes:
measure: Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization
timeFrame: 12 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
city: Chevy Chase
country: United States
state: Maryland
city: Hackensack
country: United States
facility: Hackensack University Medical Center Cancer Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: Marc Schwartz, PhD
role: STUDY_CHAIR
References:
citation: Schwartz MD, Peshkin BN, Isaacs C, Willey S, Valdimarsdottir HB, Nusbaum R, Hooker G, O'Neill S, Jandorf L, Kelly SP, Heinzmann J, Zidell A, Khoury K. Randomized trial of proactive rapid genetic counseling versus usual care for newly diagnosed breast cancer patients. Breast Cancer Res Treat. 2018 Aug;170(3):517-524. doi: 10.1007/s10549-018-4773-3. Epub 2018 Apr 2.