Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Ovarian Cancer, Cancer, Healthy Studies |
Therapuetic Areas: | Oncology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2018 |
Start Date: | December 2, 2010 |
End Date: | March 2019 |
Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas
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.
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.
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.
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
We found this trial at
3
sites
Sylmar, California 91342
Principal Investigator: Nancy Feldman, MD
Phone: 818-364-3562
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Duarte, California 91010
Principal Investigator: Jeffrey Ne Weitzel
Phone: 800-826-4673
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Los Angeles, California 90033
Principal Investigator: Charite Ricker, MS, CGC
Phone: 323-226-2289
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