Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Sylmar 5400784, California 5332921 and other locations
Dates
study started
study ends around

Description

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.

Official Title

Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Keywords

No Evidence of Disease, BRCA1 Syndrome, BRCA2 Syndrome, Hereditary Female Breast Carcinoma, Hereditary Ovarian Carcinoma, Counseling, Educational Early Intervention, Methods, educational intervention

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join if...

  • Previous participation in GCRA

Locations

  • Olive View-UCLA Medical Center
    Sylmar 5400784 California 5332921 91342 United States
  • University of Southern California-Keck School of Medicine
    Los Angeles 5368361 California 5332921 90033 United States
  • City of Hope Medical Center
    Duarte 5344147 California 5332921 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
City of Hope Medical Center
ID
NCT01230346
Study Type
Interventional
Participants
About 493 people participating
Last Updated