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

NCT01230346 | Active Not Recruiting DMC

• 2 other identifiers: 08237NCI-2010-01998
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

No Evidence of Disease; BRCA1 Syndrome; BRCA2 Syndrome; Hereditary Female Breast Carcinoma; Hereditary Ovarian Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Perceived barriers to GCRA through no-show telephone interviews

  One week after genetic cancer risk assessment (GCRA)

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive a culturally-informed adapted motivational interviewing telephone call.

Other: questionnaire administration; Other: survey administration; Other: counseling intervention; Other: educational intervention

Arm II

EXPERIMENTAL

Patients participate in a controlled condition comprising a health habits intervention group.

Other: questionnaire administration; Other: survey administration; Other: counseling intervention

Arm III

ACTIVE COMPARATOR

Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.

Other: questionnaire administration; Other: survey administration

Interventions

questionnaire administration OTHER

Ancillary studies

Arm I; Arm II; Arm III

survey administration OTHER

Ancillary studies

Arm I; Arm II; Arm III

counseling intervention OTHER

Telephone intervention

Also known as: counseling and communications studies

Arm I; Arm II

educational intervention OTHER

Telephone intervention

Also known as: intervention, educational

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous participation in GCRA

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

University of Southern California-Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

MeSH Terms

Interventions

Counseling; Early Intervention, Educational; Methods

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Investigative Techniques

Study Officials

• Bita Nehoray

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: October 29, 2010
• Study Start: September 3, 2010
• Primary Completion: November 10, 2016
• Study Completion (Estimated): September 25, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (3)