Genetic Counseling for Breast Cancer Survivors (GC for BC)

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Video and Booklet; Behavioral: Factsheet

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.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: Factsheet; Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Rate of Initial Survey Responses	Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.	Up to 8 months
Part 2: Rate of Participation	Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.	Up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Impact	Self-Reported Feedback Scoring Method: Frequencies and descriptives will be calculated for response options. Positive feedback rate of Psychoeducational Intervention (PEI) group compared to the Factsheet group.	Up to 8 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Susan Vadaparampil, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2012
• Primary Completion (Actual): July 11, 2016
• Study Completion (Actual): July 12, 2019

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: triple negative breast cancer; genetic counseling; BRCA 1; BRCA 2; female breast cancer; hereditary breast and ovarian cancer (HBOC); bilateral breast cancer; breast cancer diagnosis; psychoeducational intervention (PEI); cancer education materials
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MCC-16723

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No