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Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
Conditions
No Evidence of Disease - BRCA1 Syndrome - BRCA2 Syndrome - Hereditary Female Breast Carcinoma - Hereditary Ovarian Carcinoma
Conditions: official terms
Breast Neoplasms - Carcinoma - Ovarian Neoplasms - Syndrome
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: questionnaire administration
Type: Other
Name: survey administration
Type: Other
Name: counseling intervention
Type: Other
Name: educational intervention
Type: Other
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
- 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
City of Hope Medical Center
Duarte, California, United States
University of Southern California-Keck School of Medicine
Status: Recruiting
Contact: Jeffrey Ne Weitzel - 800-826-4673
Los Angeles, California, United States
Olive View-UCLA Medical Center
Status: Recruiting
Contact: Charite Ricker, MS, CGC - 323-226-2289 - ricker@usc.edu
Sylmar, California, United States
Status: Recruiting
Contact: Lori Viveros, MPH - 818-364-3562 - LViveros@mednet.ucla.edu
Start Date
September 2010
Sponsors
City of Hope Medical Center
Source
City of Hope Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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