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Genetic Counseling for Breast Cancer Survivors (GC for BC)

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ClinicalTrials.gov Identifier: NCT02451735
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Video and Booklet Behavioral: Factsheet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Genetic Counseling for Breast Cancer Survivors (GC for BC)
Actual Study Start Date : July 27, 2012
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : July 12, 2019


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.




Primary Outcome Measures :
  1. Part 1: Rate of Initial Survey Responses [ Time Frame: Up to 8 months ]
    Intervention Development: Rate of feedback of draft materials required to complete a formative evaluation.

  2. Part 2: Rate of Participation [ Time Frame: Up to 8 months ]
    Participation in the Psychoeducational Intervention (PEI) group compared to the Factsheet group.


Secondary Outcome Measures :
  1. Rate of Impact [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451735


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Susan Vadaparampil H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02451735     History of Changes
Other Study ID Numbers: MCC-16723
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases