Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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To conduct a randomized trial of a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention.
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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.
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To explore patients' experiences with the pre-GCRA intervention through post-intervention telephone interviews.
SECONDARY OBJECTIVES:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients receive a culturally-informed adapted motivational interviewing telephone call. |
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies
Other: counseling intervention
Telephone intervention
Other Names:
Other: educational intervention
Telephone intervention
Other Names:
|
| Experimental: Arm II Patients participate in a controlled condition comprising a health habits intervention group. |
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies
Other: counseling intervention
Telephone intervention
Other Names:
|
| Active Comparator: Arm III Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. |
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Perceived barriers to GCRA through no-show telephone interviews [One week after genetic cancer risk assessment (GCRA)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Meet NCCN criteria for consideration of genetic testing for hereditary breast cancer
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Willing to sign consent
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Pregnant women and women of child-bearing potential are eligible for participation in this study
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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)
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Women who are under- or uninsured and come from low-income communities
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Ability to understand English or Spanish
Exclusion Criteria:
- Previous participation in GCRA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
| 2 | University of Southern California-Keck School of Medicine | Los Angeles | California | United States | 90033 |
| 3 | Olive View-UCLA Medical Center | Sylmar | California | United States | 91342 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jeffrey Weitzel, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 08237
- NCI-2010-01998