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NCT Number: NCT02993068

Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)

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.

Why the study stopped: Accrual Limit
Suspended

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Key information

Conditions

BARD1 Gene Mutation BRCA1 Gene Mutation BRCA2 Gene Mutation BRIP1 Gene Mutation Breast Diseases Breast Neoplasms Estrogen Receptor Negative HER2/Neu Negative MLH1 Gene Mutation MSH2 Gene Mutation MSH6 Gene Mutation Neoplasms Neoplasms by Site PALB2 Gene Mutation PMS2 Gene Mutation Progesterone Receptor Negative RAD51C Gene Mutation RAD51D Gene Mutation Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Triple-Negative Breast Carcinoma

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center, Houston, Texas, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

  • To test the effects of online genetic education versus telephone genetic counseling on testing completion rates.
  • To evaluate the role of psychological and social variables in women's reactions to genetic testing for ovarian cancer risk with variable education strategies.
  • To consider the effects of variations of genetic education/counseling on genetic knowledge, satisfaction with the decision to undergo testing, and family communication.
  • To examine the cancer screening and prevention behaviors, as well as cascade testing behaviors among patients who tested positive for a pathogenic variant.
  • To determine factors contributing to non-completion of genetic testing in subjects enrolled in a genetic testing trial.
  • To determine the impact of pre- and/or post-test genetic counseling on family communication, genetic testing concerns and screening behaviors.

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Educational Intervention

Other

Watch genetic testing online educational video

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Genetic Counseling

Other

Receive post-telephone genetic counseling

laboratory biomarker analysis

Other

Correlative studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Mean cancer stress scores

    Time frame: Up to 4 years

    Mean cancer stress scores are measured on the Impact of Events Scale (IES), a 15-item self-report measure that assesses subjective distress caused by traumatic events, which may include a positive genetic test result.There are two subscales, Intrusion and Avoidance, used to calculate a total. The range for Intrusion is 0-35 and the range for Avoidance is 0-40. The range of the total score is 0-75. Higher scores reflect more stressful impact, and therefore, a worse outcome.

    Subscales are summed to compute the total score.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Dec 14, 2016
Registry last updated
Aug 26, 2026

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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