Active — Not RecruitingNot Applicable

Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer

United States493 participantsStarted 2010-09-03

Plain-language summary

This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals who have a personal history of hereditary breast or ovarian cancer; a subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis * Meet NCCN criteria for consideration of genetic testing for hereditary breast cancer * Willing to sign consent * Pregnant women and women of child-bearing potential are eligible for participation in this study * Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin) * Women who are under- or uninsured and come from low-income communities * Ability to understand English or Spanish Exclusion Criteria: * Previous participation in GCRA

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge

Timeframe: One week after genetic cancer risk assessment (GCRA)

Experiences with the pre-GCRA intervention through post-intervention telephone interviews

Timeframe: One week after genetic cancer risk assessment (GCRA)

Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques

Timeframe: One week after genetic cancer risk assessment (GCRA)

Trial details

NCT IDNCT01230346

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11-10

View on ClinicalTrials.gov More No Evidence of Disease trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge

Timeframe: One week after genetic cancer risk assessment (GCRA)

Experiences with the pre-GCRA intervention through post-intervention telephone interviews

Timeframe: One week after genetic cancer risk assessment (GCRA)

Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques

Timeframe: One week after genetic cancer risk assessment (GCRA)