Back to resultsGenetic Counseling for Breast Cancer Survivors (GC for BC)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video and Booklet
Factsheet
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring female breast cancer, bilateral breast cancer, triple negative breast cancer, breast cancer diagnosis, BRCA 1, BRCA 2, psychoeducational intervention (PEI), genetic counseling, hereditary breast and ovarian cancer (HBOC), cancer education materials
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.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Intervention Development
Intervention Pilot - Intervention Group
Intervention Pilot - Control Group
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
Part 1: Rate of Initial Survey Responses
Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.
Part 2: Rate of Participation
Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02451735
First Posted
May 18, 2015
Last Updated
November 6, 2019
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02451735
Brief Title
Genetic Counseling for Breast Cancer Survivors (GC for BC)
Official Title
Genetic Counseling for Breast Cancer Survivors (GC for BC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 27, 2012 (Actual)
Primary Completion Date
July 11, 2016 (Actual)
Study Completion Date
July 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
female breast cancer, bilateral breast cancer, triple negative breast cancer, breast cancer diagnosis, BRCA 1, BRCA 2, psychoeducational intervention (PEI), genetic counseling, hereditary breast and ovarian cancer (HBOC), cancer education materials
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Development
Arm Type
No Intervention
Arm 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.
Arm Title
Intervention Pilot - Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Intervention Pilot - Control Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Video and Booklet
Intervention Description
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
Intervention Name(s)
Factsheet
Intervention Description
Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.
Primary Outcome Measure Information:
Title
Part 1: Rate of Initial Survey Responses
Description
Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.
Time Frame
Up to 8 months
Title
Part 2: Rate of Participation
Description
Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.
Time Frame
Up to 8 months
Secondary Outcome Measure Information:
Title
Rate of Impact
Description
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.
Time Frame
Up to 8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Vadaparampil
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Genetic Counseling for Breast Cancer Survivors (GC for BC)
We'll reach out to this number within 24 hrs