Genetic Counseling for Breast Cancer Survivors (GC for BC)

Breast Cancer Clinical Trial

Official title:

Genetic Counseling for Breast Cancer Survivors (GC for BC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451735
• Other study ID #: MCC-16723
• Status: Completed
• Phase: N/A
• Start date: July 27, 2012
• Est. completion date: July 12, 2019

Study information

• Verified date: November 2019
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: July 12, 2019
• Est. primary completion date: July 11, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Part 2: Rate of Participation	Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.	Up to 8 months
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trials website