Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
NCT Number: NCT04245176
This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer
This research study involves an expedited and surgery-specific form of genetic counseling.
The names of the study methods involved in this trial are/is:
* Quantitative genetic counseling (discussion is guided by tables and graphs) * Standard genetic counseling
Looking for future studies?
Notify Me18 year–79 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard genetic counseling: Standard of care discussion
Quantitative genetic counseling: Discussion is guided by tables and graphs.
Time frame: 1 month
A short survey, self-developed in conjunction with the Dana Farber Cancer Institute professional survey core, will be used to compare changes in patients' personal contralateral breast cancer (CBC) risk assessment after quantitative versus standard genetic counseling. The question reads: "By the time you turn 80 years old, what do you believe is the chance you will develop cancer in the other (unaffected) breast?" and answer options are in 10% increments (ie. 0-10%, 11-20%, 21-30%). Their individual assessment of their risk will be collected before and after genetic counseling and will be compared to CBCRisk (for those without gene mutations) or ASK2ME (for those with gene mutations).
Time frame: 1 month
Patient's will be surveyed about their personal propensity to choose a bilateral mastectomy as the surgical treatment of a unilateral cancer before and after quantitative vs. standard counseling. This survey question was self-developed in conjunction with the Dana Farber Cancer Institute professional survey core. The question reads: "How likely or unlikely are you to choose surgery to remove both breasts (bilateral mastectomy) for your cancer in one breast (unilateral or one-sided breast cancer)?"s answer options include the following: "Very unlikely, Somewhat unlikely, Unsure (neither likely nor unlikely), Somewhat likely, Very likely).
Time frame: 6 Months
Breast cancer patient satisfaction with genetic counseling practices,comparing the delivery of results by quantitative counseling versus standard counseling, as measured by the Genetic Testing Satisfaction Survey (GTS).
Time frame: 6 Months
CPM rates will be measured and compared between patients who undergo quantitative versus standard genetic counseling.
Time frame: 6 months
Patients' level of anxiety will be compared between quantitative versus standard genetic counseling to monitor that we are avoiding undue stress on the patients. We will use the Patient-Reported Outcomes Information System (PROMIS) anxiety scale. Scores can range from 8-40, with 40 indicating worse anxiety.
Time frame: 6 months
Decisional regret will be measured and compared between quantitative versus standard genetic counseling, for both the decision to undergo genetic testing and the surgical choice that was made.
Brigham and Women's Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04074720
Breast Cancer, Breast Carcinoma In Situ
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT01556243
Adenocarcinoma, Breast Cancer
Hot Springs, Arkansas, United States
View Trial DetailsNCT03387553
Breast Cancer, Breast Cancer Female
Tampa, Florida, United States
View Trial DetailsNCT05263362
Breast Cancer, Breast Cancer Female
Dordrecht, Netherlands
View Trial Details