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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01230346

Enrollment

493

Registered

2010-10-29

Start date

2010-09-03

Completion date

2026-09-25

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERquestionnaire administration

Ancillary studies

OTHERsurvey administration

Ancillary studies

OTHERcounseling intervention

Telephone intervention

OTHEReducational intervention

Telephone intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026