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Genetic counseling by phone may ease cancer fears in High-Risk women

NCT ID NCT02993068

Knowledge-focused Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study looks at whether watching an online genetics video, with or without phone counseling from a genetic counselor, can reduce the stress women feel about their cancer risk. It involves 5,200 women aged 30 or older who have had triple-negative breast cancer and still have at least one ovary. The goal is to learn which approach works best for managing cancer-related distress.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2017

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

BARD1-related cancer predisposition BRCA2-related cancer predisposition estrogen-receptor negative breast cancer Her2-receptor negative breast cancer Lynch syndrome 1 PALB2-related cancer predisposition RAD51C-related cancer predisposition RAD51D-related cancer predisposition triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BARD1 gene mutation BRCA1 gene mutation BRCA2 gene mutation BRIP1 gene mutation Estrogen receptor negative HER2/neu negative MLH1 gene mutation MSH2 gene mutation MSH6 gene mutation PALB2 gene mutation PMS2 gene mutation Progesterone receptor negative RAD51C gene mutation RAD51D gene mutation Triple-negative breast carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

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