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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01998 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive a culturally-informed adapted motivational interviewing telephone call. |
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| Arm II | Experimental | Patients participate in a controlled condition comprising a health habits intervention group. |
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| Arm III | Active Comparator | Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | One week after genetic cancer risk assessment (GCRA) |
| 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 | 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. | One week after genetic cancer risk assessment (GCRA) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived barriers to GCRA through no-show telephone interviews | One week after genetic cancer risk assessment (GCRA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bita Nehoray | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| University of Southern California-Keck School of Medicine |
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| survey administration | Other | Ancillary studies |
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| counseling intervention | Other | Telephone intervention |
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| educational intervention | Other | Telephone intervention |
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| Los Angeles |
| California |
| 90033 |
| United States |
| Olive View-UCLA Medical Center | Sylmar | California | 91342 | United States |
| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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