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

N/AActive Not RecruitingNCT01230346

City of Hope Medical Center493 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

493

Conditions

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

Interventions

questionnaire administrationOTHER

Ancillary studies

survey administrationOTHER

Ancillary studies

counseling interventionOTHER

Telephone intervention

educational intervention

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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.

Time frame: One week after genetic cancer risk assessment (GCRA)

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

Time frame: 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.

Time frame: One week after genetic cancer risk assessment (GCRA)

Secondary Outcomes

Perceived barriers to GCRA through no-show telephone interviews

Time frame: One week after genetic cancer risk assessment (GCRA)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.