Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer
6. November 2017 aktualisiert von: Memorial Sloan Kettering Cancer Center
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
108
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10065
- Memorial Sloan Kettering Cancer Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 50 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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To determine the relative proportions of women offered genetic testing after a breast cancer diagnosis who decide to have BRCA testing
Zeitfenster: 2 years
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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).
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2 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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To determine the relative proportions of women who decide to undergo prophylactic mastectomy (PM)
Zeitfenster: 2 years
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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.
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2 years
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To assess the factors associated with the decision to choose pre- or post surgical testing.
Zeitfenster: 2 years
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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) .
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2 years
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Mark Robson, MD, Memorial Sloan Kettering Cancer Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
28. Juni 2011
Primärer Abschluss (Tatsächlich)
3. November 2017
Studienabschluss (Tatsächlich)
3. November 2017
Studienanmeldedaten
Zuerst eingereicht
29. Juni 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. Juni 2011
Zuerst gepostet (Schätzen)
1. Juli 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. November 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. November 2017
Zuletzt verifiziert
1. November 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 11-086
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