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Trial Title:
Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
NCT ID:
NCT01230346
Condition:
No Evidence of Disease
BRCA1 Syndrome
BRCA2 Syndrome
Hereditary Female Breast Carcinoma
Hereditary Ovarian Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
questionnaire administration
Description:
Ancillary studies
Arm group label:
Arm I
Arm group label:
Arm II
Arm group label:
Arm III
Intervention type:
Other
Intervention name:
survey administration
Description:
Ancillary studies
Arm group label:
Arm I
Arm group label:
Arm II
Arm group label:
Arm III
Intervention type:
Other
Intervention name:
counseling intervention
Description:
Telephone intervention
Arm group label:
Arm I
Arm group label:
Arm II
Other name:
counseling and communications studies
Intervention type:
Other
Intervention name:
educational intervention
Description:
Telephone intervention
Arm group label:
Arm I
Other name:
intervention, educational
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
University of Southern California-Keck School of Medicine
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Facility:
Name:
Olive View-UCLA Medical Center
Address:
City:
Sylmar
Zip:
91342
Country:
United States
Start date:
September 3, 2010
Completion date:
December 31, 2024
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01230346
