Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
NCT ID: NCT01230346
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
493 participants
INTERVENTIONAL
2010-09-03
2026-09-25
Brief Summary
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Detailed Description
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I. To conduct a randomized trial of a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention.
II. To evaluate the effect of the pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual care) on levels of anxiety, perceived personal control and cancer genetics knowledge.
III. To explore patients' experiences with the pre-GCRA intervention through post-intervention telephone interviews.
SECONDARY OBJECTIVES:
I. To explore patients' perceived barriers to GCRA through no-show telephone interviews.
OUTLINE:
Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive a culturally-informed adapted motivational interviewing telephone call.
ARM II: Patients participate in a controlled condition comprising a health habits intervention group.
ARM III: Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. All patients are mailed standard new patient packets containing questionnaires on demographics and personal health history, and a family history form. All patients then undergo genetic cancer risk assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I
Patients receive a culturally-informed adapted motivational interviewing telephone call.
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
counseling intervention
Telephone intervention
educational intervention
Telephone intervention
Arm II
Patients participate in a controlled condition comprising a health habits intervention group.
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
counseling intervention
Telephone intervention
Arm III
Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
Interventions
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questionnaire administration
Ancillary studies
survey administration
Ancillary studies
counseling intervention
Telephone intervention
educational intervention
Telephone intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Bita Nehoray
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
University of Southern California-Keck School of Medicine
Los Angeles, California, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Countries
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Other Identifiers
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NCI-2010-01998
Identifier Type: -
Identifier Source: secondary_id
08237
Identifier Type: -
Identifier Source: org_study_id