Genetic Counseling for Breast Cancer Survivors (GC for BC)

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Factsheet; Behavioral: Video and Booklet

• Registration Number: NCT02451735
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Timeline

• Study Start: 2012-07-27
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-22
• Primary Completion: 2016-07-11
• Study Completion: 2019-07-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention Pilot - Control Group	Factsheet	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.
Intervention Pilot - Intervention Group	Video and Booklet	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of Impact	Up to 8 months	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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States