Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer

Study Overview
=================
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.

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.

Official Title
-----------------
Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas

Conditions
-----------------
No Evidence of Disease, BRCA1 Syndrome, BRCA2 Syndrome, Hereditary Female Breast Carcinoma, Hereditary Ovarian Carcinoma

Intervention / Treatment
-----------------
* Other: questionnaire administration
* Other: survey administration
* Other: counseling intervention
* Other: educational intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive a culturally-informed adapted motivational interviewing telephone call. | Other: questionnaire administration<br>* Ancillary studies<br>Other: survey administration<br>* Ancillary studies<br>Other: counseling intervention<br>* Telephone intervention<br>* Other names: counseling and communications studies;Other: educational intervention<br>* Telephone intervention<br>* Other names: intervention, educational;|
| Experimental: Arm II<br>Patients participate in a controlled condition comprising a health habits intervention group. | Other: questionnaire administration<br>* Ancillary studies<br>Other: survey administration<br>* Ancillary studies<br>Other: counseling intervention<br>* Telephone intervention<br>* Other names: counseling and communications studies;|
| Active Comparator: Arm III<br>Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. | Other: questionnaire administration<br>* Ancillary studies<br>Other: survey administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived barriers to GCRA through no-show telephone interviews |  | One week after genetic cancer risk assessment (GCRA) |