Genetic Counseling for Breast Cancer Survivors (GC for BC)

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Factsheet; Behavioral: Video and Booklet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02451735

MCC-16723

Details and patient eligibility

About

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

Full 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.

Enrollment: 157 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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157 participants in 3 patient groups

Intervention Development

No Intervention group

Description:

Psychoeducational Intervention (PEI) development. PEIs include printed and DVD materials, and represent a commonly used and effective approach to implement theoretically based individual-level interventions. These materials serve as important sources of information for the general public, cancer patients, and survivors from a variety of backgrounds, including populations with limited health literacy. An interview and feedback collection process will take place to provide data to improve current PEI materials.

Intervention Pilot - Intervention Group

Experimental group

Description:

The intervention group will receive the PEI materials: video and booklet. Self-reported feedback will be collected and reviewed to compare response with the control group.

Treatment:

Behavioral: Video and Booklet

Intervention Pilot - Control Group

Active Comparator group

Description:

The control group will receive a patient factsheet about Genetic Counseling (GC). Self-reported feedback will be collected and reviewed to compare response with the intervention group.

Treatment:

Behavioral: Factsheet