Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer
This study is currently recruiting participants.
Verified February 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01386411
First received: June 29, 2011
Last updated: February 8, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2014 |
| Estimated Primary Completion Date: | June 2014 (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
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: | February 8, 2013 |
| 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 May 21, 2013