Genetic Counseling for Breast Cancer Survivors (GC for BC)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:July 27, 2012
End Date:July 2019

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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

Part 1: Intervention Development

Aim 1: Develop a psychoeducational intervention (PEI) for high-risk breast cancer survivors
about genetic counseling (GC) and hereditary breast and ovarian cancer (HBOC).

Part 2: Intervention Pilot

Aim 2: Assess the feasibility and acceptability of a PEI from the perspective of the BC
patients and health care professionals.

Exploratory Aim 3: Estimate the preliminary efficacy of the PEI compared to standard clinical
care. We hypothesize that women in the intervention group will have higher uptake of GC,
greater increases in knowledge, and more perceived benefits related to GC compared to the
control group.

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 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 GC at the time of
recruitment;

- 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.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Susan Vadaparampil, Ph.D., MPH
Phone: 813-745-1015
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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