NCT00262899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

4.9 years

First QC Date

December 6, 2005

Last Update Submit

January 4, 2013

Conditions

Breast CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentductal breast carcinoma in situbreast cancer in situstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (5)

  • Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization

    1, 6, and 12 months

  • 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

  • Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization

    1, 6, and 12 months

  • Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization

    1 month

  • Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization

    1 and 6 months

Secondary Outcomes (1)

  • Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization

    12 months

Study Arms (2)

Rapid genetic counseling

EXPERIMENTAL

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 interventionOther: educational interventionProcedure: psychosocial assessment and care

Usual Care

NO INTERVENTION

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.

Interventions

counseling interventionBEHAVIORAL
Rapid genetic counseling
educational interventionOTHER
Rapid genetic counseling
psychosocial assessment and carePROCEDURE
Rapid genetic counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Unknown Facility

Chevy Chase, Maryland, 20815, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 29611029DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

CounselingEarly Intervention, EducationalPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health ServicesRehabilitationTherapeutics

Study Officials

  • Marc Schwartz, PhD

    Lombardi Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Oncology

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

August 1, 2005

Primary Completion

July 1, 2010

Study Completion

July 1, 2011

Last Updated

January 7, 2013

Record last verified: 2013-01

Locations

US(4)