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

Plain-language summary

This study investigates how women newly diagnosed with breast cancer (or DCIS) make decisions about undergoing genetic testing such as BRCA. It included women over 18 who were appropriate candidates for genetic testing. It is an observational (non-phase) study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Memorial Sloan Kettering Cancer Center

Intervention

BRCA testing and questionnaire assessments

Start date

6/28/2011

Estimated completion

11/3/2017

Countries

United States

Related genes

Locations

• New York, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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