Genetic Counseling for Breast Cancer Survivors (GC for BC) (NCT02451735) | Clinical Trial Compass
CompletedNot Applicable
Genetic Counseling for Breast Cancer Survivors (GC for BC)
United States157 participantsStarted 2012-07-27
Plain-language summary
The purpose of this study is to review and evaluate the effectiveness of new educational materials (informational booklet \& DVD) that promote participation in genetic counseling among breast cancer survivors.
There are two phases to this study:
Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the effectiveness of the newly developed educational materials
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Part 1: Female breast cancer patients at Moffitt Cancer Center (MCC) are eligible to participate if they:
* are \> 18 years of age;
* have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
* are capable of speaking and reading standard English;
* have not attended or scheduled an upcoming appointment for genetic counseling at the time of recruitment;
* are within 18 months of their breast cancer (BC) diagnosis;
* have a previous diagnosis of breast cancer or;
* received a referral letter for GC from their MCC physician;
* breast cancer at age 50 or below;
* bilateral breast cancer;
* multiple cancers except basal cell carcinoma;
* triple negative breast cancer;
* ovarian cancer or fallopian tube cancer at any age;
* of Ashkenazi Jewish descent;
* have 2 or more blood relatives diagnosed with breast cancer;
* have any blood relatives diagnosed with bilateral breast cancer;
* a first degree relative diagnosed with breast cancer below age 50;
* have blood relatives diagnosed with ovarian cancer;
* have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer;
* have a known cancer gene mutation (such as BRCA 1/2;
* have any male relatives diagnosed with breast cancer ; and
* have a mailing address and working telephone number; and
* provide written informed consent.
Part 2: Female BC patients at MCC are eligible to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Rate of Initial Survey Responses
Timeframe: Up to 8 months
2
Part 2: Rate of Participation
Timeframe: Up to 8 months
Trial details
NCT IDNCT02451735
SponsorH. Lee Moffitt Cancer Center and Research Institute