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Breast CancerPhase 3NCT00262899

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

A Phase 3 study testing counseling intervention, educational intervention and psychosocial assessment and care in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Georgetown University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
counseling intervention, educational intervention and psychosocial assessment and care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
331 participants
Where
4 sitesUnited States
Study dates
Aug 2005to Jul 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

4 sites in 1 country.

United States4 sites

  • Study site

    Chevy Chase, Maryland, 20815

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, 07601

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
counseling intervention, educational intervention, psychosocial assessment and care
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
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • counseling interventionBehavioural

  • educational interventionOther

  • psychosocial assessment and careProcedure or surgery

Study groups in NCT00262899
Study groupRoleWhat they receive
Rapid genetic counselingExperimentalFollowing 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.
Receives: Behavioral: counseling intervention; Other: educational intervention; Procedure: psychosocial assessment and care
Usual CareNo interventionUsual 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1, 6, and 12 months

  2. Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization

    Measured: 1, 6, and 12 months

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

    Measured: 1, 6, and 12 months

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

    Measured: 1 month

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

    Measured: 1 and 6 months

Secondary outcomes (1)

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionJul 2010
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262899
Sponsor's protocol ID
CDR0000450155
Other IDs
R01CA108933, R01CA074861, P30CA051008, GUMC-2004-212
Status last verified
Jan 2013
First submitted
6 Dec 2005
Last updated
7 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29611029

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing counseling intervention, educational intervention and psychosocial assessment and care in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Georgetown University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.

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