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

Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas

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.

Study Overview

• Status: Active, not recruiting
• Conditions: BRCA1 Syndrome; BRCA2 Syndrome; No Evidence of Disease; Hereditary Ovarian Carcinoma; Hereditary Female Breast Carcinoma
• Intervention / Treatment: Other: questionnaire administration; Other: survey administration; Other: counseling intervention; Other: educational intervention

Detailed Description

PRIMARY OBJECTIVES:

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.

• Study Type: Interventional
• Enrollment (Actual): 493
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California-Keck School of Medicine
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients receive a culturally-informed adapted motivational interviewing telephone call.	Other: questionnaire administration; Ancillary studies; Other: survey administration; Ancillary studies; Other: counseling intervention; Telephone intervention; Other Names: counseling and communications studies; Other: educational intervention; Telephone intervention; Other Names: intervention, educational
Experimental: Arm II; Patients participate in a controlled condition comprising a health habits intervention group.	Other: questionnaire administration; Ancillary studies; Other: survey administration; Ancillary studies; Other: counseling intervention; Telephone intervention; Other Names: counseling and communications studies
Active Comparator: Arm III; Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.	Other: questionnaire administration; Ancillary studies; Other: survey administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Tested using 3 x 3 repeated measures analysis of covariance (ANCOVA)s in which the within subjects variables are anxiety or perceived control, the between groups variable is group membership, and covariates include fatalism and other appropriate moderators.	One week after genetic cancer risk assessment (GCRA)
Experiences with the pre-GCRA intervention through post-intervention telephone interviews		One week after genetic cancer risk assessment (GCRA)
Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques	Will use a multivariate ANCOVA (MANCOVA) to test for group differences among all five preparedness scores, with step-down F ratios of each individual score, using fatalism and other moderators as covariates, as appropriate.	One week after genetic cancer risk assessment (GCRA)

Secondary Outcome Measures

Outcome Measure	Time Frame
Perceived barriers to GCRA through no-show telephone interviews	One week after genetic cancer risk assessment (GCRA)

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bita Nehoray, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2010
• Primary Completion (Actual): November 10, 2016
• Study Completion (Estimated): September 25, 2026

Study Registration Dates

• First Submitted: September 22, 2010
• First Submitted That Met QC Criteria: October 27, 2010
• First Posted (Estimated): October 29, 2010

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Disease; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Syndrome; Carcinoma; Breast Neoplasms; Investigative Techniques; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Behavioral Disciplines and Activities; Mental Health Services; Methods; Early Intervention, Educational; Counseling
• Other Study ID Numbers: 08237; NCI-2010-01998