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

Not Applicable

Active, not recruiting

• Conditions: No Evidence of Disease; BRCA2 Syndrome; BRCA1 Syndrome; Hereditary Female Breast Carcinoma; Hereditary Ovarian Carcinoma
• Interventions: Other: questionnaire administration; Other: survey administration; Other: counseling intervention; Other: educational intervention

• Registration Number: NCT01230346
• Lead Sponsor: City of Hope Medical Center

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.

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 Timeline

• Study Start: 2010-09-03
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-29
• Primary Completion: 2016-11-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Study Completion: 2025-10-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 493

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	questionnaire administration	Patients receive a culturally-informed adapted motivational interviewing telephone call.
Arm I	counseling intervention	Patients receive a culturally-informed adapted motivational interviewing telephone call.
Arm I	survey administration	Patients receive a culturally-informed adapted motivational interviewing telephone call.
Arm II	survey administration	Patients participate in a controlled condition comprising a health habits intervention group.
Arm III	survey administration	Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.
Arm I	educational intervention	Patients receive a culturally-informed adapted motivational interviewing telephone call.
Arm II	questionnaire administration	Patients participate in a controlled condition comprising a health habits intervention group.
Arm III	questionnaire administration	Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.
Arm II	counseling intervention	Patients participate in a controlled condition comprising a health habits intervention group.

Primary Outcome Measures

Name	Time	Method
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	One week after genetic cancer risk assessment (GCRA)	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.
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	One week after genetic cancer risk assessment (GCRA)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Olive View-UCLA Medical Center; 🇺🇸 Sylmar, California, United States

University of Southern California-Keck School of Medicine; 🇺🇸 Los Angeles, California, United States