Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01386411
First received: June 29, 2011
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

Genes are the "blueprints" for our bodies. Some people are born with an abnormal copy ("mutation") of a gene. These people may have a higher chance of getting a disease. Different mutations in different genes cause different diseases. Some women get breast cancer because they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These women also have a higher chance of getting ovary cancer. Women with breast cancer and an abnormal copy of BRCA1 or BRCA2 also have a higher chance of getting a second breast cancer in their other breast. Because of this, women who might have a mutation may have genetic testing soon after their breast cancer diagnosis to learn about their risks of getting another cancer.

Genetic testing may be done right after a woman has been diagnosed with breast cancer. It may also be done later, after surgery is done to treat the cancer. The investigators do not know when it is best to do genetic testing. The investigators are doing this study to try to understand whether women prefer testing before or after surgery. The investigator also want to find out how they feel about their choice later on, when their diagnosis in more in their past.


Condition Intervention
Breast Cancer
Genetic: BRCA testing and questionnaire assessments

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the relative proportions of women offered genetic testing after a breast cancer diagnosis who decide to have BRCA testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Either before completing definitive local surgical treatment (pre-surgical testing), after definitive surgical treatment (post-surgical) Women will be evaluated for their levels of general and cancer specific distress, coping style, and stage of decision-making with respect to PM (as this is the primary clinical reason for undergoing immediate testing).


Secondary Outcome Measures:
  • To determine the relative proportions of women who decide to undergo prophylactic mastectomy (PM) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The decision-making on prophylactic mastectomy (PM) will be obtained from the immediate and delayed BRCA genetic testers at Assessment 3. This will be a binary outcome of PM vs. no PM.

  • To assess the factors associated with the decision to choose pre- or post surgical testing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will compare the BRCA genetic testers (pooling immediate and delayed to boost the sample size) and the decliners on the summary scores of several psychosocial assessments using independent-sample t-tests for continuous variables (e.g., distress as measured by the BSI and IES) and non-parametric tests for categorical variables such as exact binomial test, Fisher's exact test, or the Chi-square test as appropriate (e.g., the blunters vs. monitors dichotomization) .

  • To assess regret experienced by women choosing to undergo either pre- or post-surgical testing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Regret scores with respect to genetic testing will be summarized (averages and confidence intervals) in women undergoing immediate, delayed, or no BRCA genetic testing (including women in the Decliner groups A, B, and C, who will be analyzed as part of the "no genetic testing" group).

  • To delineate factors associated with regret about the timing of genetic testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    particularly the interaction between regret, timing of genetic testing, level of distress at the time of the decision about genetic testing, and choice with respect to PM.


Biospecimen Retention:   Samples With DNA

peripheral blood leucocytes and/or mouthwash-collected buccal epithelial cells)


Estimated Enrollment: 225
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women with Breast Cancer
The proposed investigation is a prospective cohort study. Women with newly diagnosed breast cancer will decide whether to undergo BRCA testing either before or after completion of local surgical treatment.
Genetic: BRCA testing and questionnaire assessments
If they consent to enroll, they will complete an instrument evaluating their beliefs regarding the value of genetic testing (Assessment 1). After that, they will decide whether they wish to attend an information session on genetic predisposition. If they do, after completing that information session they will complete a follow-up instrument (Assessment 2), and will then decide to either immediately donate a sample for immediate testing, or to defer the decision until after surgery. Women will be given the results of their genetic testing in the context of a standard results counseling session, after which they will continue with clinical care. They will be followed for clinical decision, especially whether or not they undergo CPM. They will also complete instruments at 6 and 12 months assessing their QoL and decision satisfaction/regret.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a prospective study of women who meet a subset of the NCCN criteria for genetic testing and are presenting to the Breast Surgery Clinic for treatment of a newly diagnosed breast cancer.

Criteria

Inclusion Criteria:

  • Diagnosis of invasive breast cancer or DCIS
  • Appropriate for genetic testing, defined as if they meeting one or more of the following criteria (note that patients may be appropriate for genetic testing even if they do not meet these criteria, but NCCN and most payers recognize these groups as clearly appropriate for testing)
  • Must be a primary malignancy (not recurrence), but can be second diagnosis if is a contralateral cancer and the first cancer was not treated with mastectomy
  • Female age ≥18,
  • If Ashkenazi Jewish: Breast cancer diagnosis ≤ 60. Subjects will be presumed to be of Ashkenazi ethnicity if Jewish religious preference is confirmed in subject and at least 1 parent, unless they explicitly endorse Sephardic, Iranian, Yemeni/Ethiopian, or Bukharan Jewish Decent, in which case non-Ashkenazi criteria will be applied.

If not Ashkenazi Jewish:

  • Breast cancer diagnosis ≤ 45 OR
  • Bilateral breast cancer, with first diagnosed ≤ 50 OR
  • Breast cancer diagnosed at any age with a male relative with breast cancer OR
  • Breast cancer diagnosis ≤ 50 with one or more of the following::

    • 1 or more relative with breast cancer ≤ 50 or
    • 1 or more relative with ovarian cancer
  • Have not completed definitive surgical treatment
  • For patients planning mastectomy for treatment, has not yet undergone mastectomy
  • For patients planning breast conservation for treatment, has not yet begun adjuvant radiation therapy

Exclusion Criteria:

  • LCIS without invasive cancer (IDC or ILC) and without DCIS
  • Previous breast cancer treated with mastectomy
  • Plan for neoadjuvant chemotherapy before surgery
  • Unable to complete English language questionnaires, as instruments have not been validated in non-English speaking populations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386411

Contacts
Contact: Mark Robson, MD 646-888-5434
Contact: Jennifer Hay, PhD 646-888-0039

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mark Robson, MD    646-888-5434      
Contact: Jennifer Hay, PhD    646-888-0039      
Principal Investigator: Mark Robson, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Mark Robson, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01386411     History of Changes
Other Study ID Numbers: 11-086
Study First Received: June 29, 2011
Last Updated: August 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Genetic testing
BRCA testing
Ashkenazi descent
11-086

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014