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OpenTrials
Completed

NCT Number: NCT02451735

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video and Booklet

Behavioral

Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.

Factsheet

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2019
First posted
May 22, 2015
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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