Clinical trial NCT02451735: Genetic Counseling for Breast Cancer Survivors (GC for BC)
Official title: Genetic Counseling for Breast Cancer Survivors (GC for BC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: female breast cancer
bilateral breast cancer
triple negative breast cancer
breast cancer diagnosis
BRCA 1
BRCA 2
psychoeducational intervention (PEI)
genetic counseling
hereditary breast and ovarian cancer (HBOC)
cancer education materials
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2015-05-22
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part 1: Rate of Initial Survey Responses
timeFrame: Up to 8 months
measure: Part 2: Rate of Participation
timeFrame: Up to 8 months
Secondary outcomes:
measure: Rate of Impact
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Susan Vadaparampil
role: PRINCIPAL_INVESTIGATOR
References: