Online Genetics Educational Video with or without Pre- and / or Post-Telephone Genetics Counseling in Assessing Cancer-Risk Distress in Patients with Triple Negative Breast Cancer

Status: Active

Description

This randomized clinical trial studies how well online genetics educational video with or without pre- and / or post-telephone genetics counseling works in assessing cancer-risk distress in patients with triple negative breast cancer. Online genetic education and telephone genetic counseling may help the doctors learn the stress a person feels about their risk of cancer.

Eligibility Criteria

Inclusion Criteria

  • Age 30 or older. Note: Participants must meet each of Criteria 1-4.
  • Have access to a healthcare provider and be willing to share genetic results with that provider
  • Have at least one ovary
  • Have a valid United States mailing address for receipt of saliva kit
  • Participants must meet any one of the following 6 criteria:
  • Diagnosed with breast cancer at age 45 or younger
  • Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 [Her2] amplified) breast cancer at 60 or younger
  • Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2
  • Have one relative with ovarian cancer
  • Have at least 2 relatives with breast cancer on the same side of the family, one of which is =< 50 years of age
  • Have one male relative with breast cancer

Exclusion Criteria

  • Personal history of ovarian cancer
  • Unable to read, speak, and understand English
  • Unable to provide informed consent
  • Unwilling to complete baseline and follow-up questionnaires
  • Unable to access the internet
  • Previous genetic testing or counseling regarding cancer risk
  • Previous bone marrow transplant
  • Previous blood transfusion (7 days prior to genetic testing)
  • Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)

Locations & Contacts

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Karen H. Lu
Phone: 713-745-8902

Washington

Seattle
University of Washington Medical Center
Status: Active
Contact: Elizabeth Mary Swisher
Email: swishere@u.washington.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To test the effects of online genetic education versus telephone genetic counseling on cancer-risk distress.

SECONDARY OBJECTIVES:

I. To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.

II. To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.

III. To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.

OUTLINE: Patients are randomized into 1 of 4 arms.

ARM A: Patients watch genetic testing online educational video and receive genetic testing online test results report.

ARM B: Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling.

ARM C: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling.

ARM D: Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Screening

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Karen H. Lu

Trial IDs

Primary ID 2016-0298
Secondary IDs NCI-2017-01600
Clinicaltrials.gov ID NCT02993068