BARD1 Gene MutationNCT02993068
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
A study testing Educational Intervention, Genetic Counseling and Laboratory Biomarker Analysis in people with BARD1 Gene Mutation and BRCA1 Gene Mutation, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- What is being tested?
- Educational Intervention, Genetic Counseling and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,200 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2017to 18 Apr 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M D Anderson Cancer Center
Houston, Texas, 77030
University of Washington Medical Center
Seattle, Washington, 98195
About this study
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.
Read the detailed description
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.
- Conditions
- BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, Estrogen Receptor Negative, HER2/Neu Negative
- Being tested
- Educational Intervention, Genetic Counseling, Laboratory Biomarker Analysis, Questionnaire Administration
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Watch genetic testing online educational video
Genetic CounselingOther
Receive post-telephone genetic counseling
Genetic CounselingOther
Receive pre-telephone genetic counseling
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (online education) | Experimental | Patients watch genetic testing online educational video and receive genetic testing online test results report. Receives: Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm B (online education, post telephone counseling) | Experimental | Patients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling. Receives: Other: Educational Intervention; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm C (online education, pre- and post-telephone counselling) | Active comparator | Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling. Receives: Other: Educational Intervention; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm D (online education, pre-telephone counseling) | Experimental | Patients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report. Receives: Other: Educational Intervention; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cancer stress scores
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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start18 Apr 2017
- Primary completion18 Apr 2028 (estimated)
- Study completion18 Apr 2028 (estimated)
Why it stopped: Accrual Limit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BARD1 Gene MutationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roni Wilke, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993068
- Sponsor's protocol ID
- 2016-0298
- Other IDs
- NCI-2017-01600, 2016-0298
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2016
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Swisher EM, Rayes N, Bowen D, Peterson CB, Norquist BM, Coffin T, Gavin K, Polinsky D, Crase J, Bakkum-Gamez JN, Blank SV, Munsell MF, Nebgen D, Fleming GF, Olopade OI, Law S, Zhou A, Levine DA, D'Andrea A, Lu KH. Remotely Delivered Cancer Genetic Testing in the Making Genetic Testing Accessible (MAGENTA) Trial: A Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1547-1555. doi: 10.1001/jamaoncol.2023.3748.
PubMed 37707822Coffin T, Bowen D, Lu K, Swisher EM, Rayes N, Norquist B, Blank SV, Levine DA, Bakkum-Gamez JN, Fleming GF, I Olopade O, Romero I, D'Andrea A, Nebgen DR, Peterson C, Munsell MF, Gavin K, Crase J, Polinsky D, Lechner R. Using Social Media to Facilitate Communication About Women's Testing: Tool Validation Study. JMIR Form Res. 2022 Sep 26;6(9):e35035. doi: 10.2196/35035.
PubMed 36155347Rayes N, Bowen DJ, Coffin T, Nebgen D, Peterson C, Munsell MF, Gavin K, Lechner R, Crase J, Polinsky D, Romero I, Blank SV, Levine DA, Norquist BM, Swisher EM, Lu KH. MAGENTA (Making Genetic testing accessible): a prospective randomized controlled trial comparing online genetic education and telephone genetic counseling for hereditary cancer genetic testing. BMC Cancer. 2019 Jul 2;19(1):648. doi: 10.1186/s12885-019-5868-x.
PubMed 31266460
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
- ClinicalTrials.gov ID
- NCT02993068
- Acronym / sponsor ID
- 2016-0298
- Conditions
- BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, Estrogen Receptor Negative, HER2/Neu Negative
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Accrual Limit
- Enrolment
- 5,200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 18 Apr 2028 (estimated)
- Study completion
- 18 Apr 2028 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A (online education) | Experimental | Other: Educational Intervention, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients watch genetic testing online educational video and receive genetic testing online test results report. |
| Arm B (online education, post telephone counseling) | Experimental | Other: Educational Intervention, Other: Genetic Counseling, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients watch genetic testing online educational video, receive genetic testing online test results report, and post-telephone genetic counseling. |
| Arm C (online education, pre- and post-telephone counselling) | Active comparator | Other: Educational Intervention, Other: Genetic Counseling, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients watch genetic testing online educational video, receive pre-telephone genetic counseling, genetic testing online test results report, and post-telephone genetic counseling. |
| Arm D (online education, pre-telephone counseling) | Experimental | Other: Educational Intervention, Other: Genetic Counseling, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients watch genetic testing online educational video, receive pre-telephone genetic counseling, and genetic testing online test results report. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalWatch genetic testing online educational video | Other | Arm A (online education), Arm B (online education, post telephone counseling), Arm C (online education, pre- and post-telephone counselling), Arm D (online education, pre-telephone counseling) |
| Genetic CounselingReceive post-telephone genetic counseling | Other | Arm B (online education, post telephone counseling), Arm C (online education, pre- and post-telephone counselling) |
| Genetic CounselingReceive pre-telephone genetic counseling | Other | Arm C (online education, pre- and post-telephone counselling), Arm D (online education, pre-telephone counseling) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (online education), Arm B (online education, post telephone counseling), Arm C (online education, pre- and post-telephone counselling), Arm D (online education, pre-telephone counseling) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (online education), Arm B (online education, post telephone counseling), Arm C (online education, pre- and post-telephone counselling), Arm D (online education, pre-telephone counseling) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 37707822Swisher EM, Rayes N, Bowen D, Peterson CB, Norquist BM, Coffin T, Gavin K, Polinsky D, Crase J, Bakkum-Gamez JN, Blank SV, Munsell MF, Nebgen D, Fleming GF, Olopade OI, Law S, Zhou A, Levine DA, D'Andrea A, Lu KH. Remotely Delivered Cancer Genetic Testing in the Making Genetic Testing Accessible (MAGENTA) Trial: A Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1547-1555. doi: 10.1001/jamaoncol.2023.3748.
- Derived from this study: PubMed 36155347Coffin T, Bowen D, Lu K, Swisher EM, Rayes N, Norquist B, Blank SV, Levine DA, Bakkum-Gamez JN, Fleming GF, I Olopade O, Romero I, D'Andrea A, Nebgen DR, Peterson C, Munsell MF, Gavin K, Crase J, Polinsky D, Lechner R. Using Social Media to Facilitate Communication About Women's Testing: Tool Validation Study. JMIR Form Res. 2022 Sep 26;6(9):e35035. doi: 10.2196/35035.
- Derived from this study: PubMed 31266460Rayes N, Bowen DJ, Coffin T, Nebgen D, Peterson C, Munsell MF, Gavin K, Lechner R, Crase J, Polinsky D, Romero I, Blank SV, Levine DA, Norquist BM, Swisher EM, Lu KH. MAGENTA (Making Genetic testing accessible): a prospective randomized controlled trial comparing online genetic education and telephone genetic counseling for hereditary cancer genetic testing. BMC Cancer. 2019 Jul 2;19(1):648. doi: 10.1186/s12885-019-5868-x.
- MD Anderson Cancer CenterLink provided by the sponsor.
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A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roni Wilke principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Genetic Counseling and Laboratory Biomarker Analysis in people with BARD1 Gene Mutation and BRCA1 Gene Mutation, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cancer stress scores (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993068, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.