Genetic Counseling for Breast Cancer Survivors (GC for BC)

NCT ID: NCT02451735

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-27
• Study Completion Date: 2019-07-12

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Development

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Pilot - Intervention Group

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.

Group Type: EXPERIMENTAL

Video and Booklet

Intervention Type: BEHAVIORAL

Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.

Intervention Pilot - Control Group

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.

Group Type: ACTIVE_COMPARATOR

Factsheet

Intervention Type: BEHAVIORAL

Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.

Interventions

Video and Booklet

Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.

Intervention Type: BEHAVIORAL

Factsheet

Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Vadaparampil

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-16723

Identifier Type: -

Identifier Source: org_study_id